Product Code: EFQ FDA unclassified

Gauze/Sponge, Internal

Unknown

The Internal Gauze/Sponge is a device used within body cavities or surgical sites to absorb fluids, maintain hemostasis, or protect underlying tissues during surgical procedures. It has not been formally classified by the FDA (unclassified status) and no regulation number has been assigned. The product code is EFQ, and regulatory status for this device type remains pending final classification action.

View on FDA

510(k)s

271

FEI Numbers

Registration Numbers

Unique Applicants

139

Years Active

Basic Information

Product Code: EFQ
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 271 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K991757	NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE	Aug 12, 1999	Substantially Equivalent	FURLONG INDUSTRIES
K991215	SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S	Jun 11, 1999	Substantially Equivalent	SYMTEX HEALTHCARE CORP.
K990974	VITOP DRESSING	Jun 09, 1999	Substantially Equivalent	WONDER & BIOENERGY HI-TECH AMERICA, INC.
K990584	GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE	Apr 23, 1999	Substantially Equivalent	BROADLINE MEDICAL INDUSTRIES
K984187	CROSSTEX NON-WOVEN SPONGES	Feb 18, 1999	Substantially Equivalent	CROSSTEX INTL.
K983016	GAUZE, SPONGES, CAT # 11-003	Feb 12, 1999	Substantially Equivalent	VITALCARE GROUP, INC.
K983348	DYNAREX TRACHEOSTOMY SPONGE	Dec 11, 1998	Substantially Equivalent	DYNAREX CORP.
K983450	STARRYSHINE GAUZE SPONGE	Nov 12, 1998	Substantially Equivalent	T.C. DENTAL PRODUCTS, INC.
K982648	JOAN II	Sep 30, 1998	Substantially Equivalent	CELANESE ACETATE CO.
K980791	DUMEX PAK-ITS WOVEN RIBBON PACKING	Apr 29, 1998	Substantially Equivalent	DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
K974316	HYDROFERA FEMORAL WICK	Feb 13, 1998	Substantially Equivalent	HYDROFERA, LLC.
K974347	BALDUR NON-STERILE COTTON SPONGES	Feb 10, 1998	Substantially Equivalent	BALDUR SYSTEMS CORP.
K973763	KENDALL CURITY IODOFORM PACKING STRIP	Dec 31, 1997	Substantially Equivalent	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K973580	INVOTEC CLEAN PAD	Dec 10, 1997	Substantially Equivalent	INVOTEC INTERNATIONAL, INC.
K973299	PIN CARE KIT	Nov 26, 1997	Substantially Equivalent	BROWN MEDICAL INDUSTRIES
K971095	OPPORTUNITY SUTURE REMOVAL KIT	Sep 16, 1997	Substantially Equivalent for Some Indications	OPPORTUNITY, INC.
K971088	OPPORTUNITY INCISION AND DRAINAGE TRAY	Sep 16, 1997	Substantially Equivalent for Some Indications	OPPORTUNITY, INC.
K971178	RAND SURGICAL SPONGE	Jun 27, 1997	Substantially Equivalent	TRANS AIRE
K971075	PRIMED PRIME-PLUS COTTON GAUZE SPONGES	Jun 22, 1997	Substantially Equivalent	PRIMELINE MEDICAL PRODUCTS, INC.
K970457	DUKAL ABD COMBINE PAD	May 08, 1997	Substantially Equivalent	DUKAL CORP.
K970455	DUKAL NON ADHERENT DRESSING	May 08, 1997	Substantially Equivalent	DUKAL CORP.
K970020	SIMAR, INC. SURGICAL DRESSING	Mar 20, 1997	Substantially Equivalent	SIMAR, INC.
K963724	GAUZE SPONGE, NON X-RAY DETECTABLE	Nov 29, 1996	Substantially Equivalent for Some Indications	GRAND MEDICAL PRODUCTS
K960615	GAUZE COMPRESS	Nov 25, 1996	Substantially Equivalent for Some Indications	CERTIFIED SAFETY MFG., INC.
K963188	DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)	Oct 30, 1996	Substantially Equivalent	CODI INTERNATIONAL BV
K962972	SURGICADE GAUZE SPONGE	Oct 11, 1996	Substantially Equivalent	ACCUNEX CANADA,INC.
K963134	DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)	Sep 06, 1996	Substantially Equivalent	IGENICS, INC.
K962227	PRO-FECT STERILE GAUZE SPONGES	Aug 19, 1996	Substantially Equivalent	NETWORK TRADING CORP. DBA GRAND INTL.
K961773	PROTEC STERILE GAUZE SPONGE	Jul 29, 1996	Substantially Equivalent	DERIVADAS DEGASA S.A. DE C.V.
K961775	PROFORE FOUR-LAYER BANDAGE SYSTEM KIT	Jul 16, 1996	Substantially Equivalent	SMITH & NEPHEW UNITED, INC.
K962234	STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)	Jun 28, 1996	Substantially Equivalent	HOWARD MEDICAL CO.
K961061	CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)	Jun 06, 1996	Substantially Equivalent for Some Indications	CODI INTERNATIONAL BV
K961581	EMERALD STERILE GAUZE SPONGE	May 28, 1996	Substantially Equivalent	EMERALD MEDICAL, INC.
K960523	NHMC DRESSING TRAY	Apr 04, 1996	Substantially Equivalent	NATIONAL HEALTHCARE MFG. CORP.
K960388	DYNAREX NON-WOVEN SPONGE	Apr 01, 1996	Substantially Equivalent	DYNAREX CORP.
K960093	PROTEC ROLL GAUZE	Mar 25, 1996	Substantially Equivalent	DERIVADAS DEGASA S.A. DE C.V.
K955527	GENERAL USE SYNTHETIC SPONGE (STERILE)	Feb 05, 1996	Substantially Equivalent	IGENICS, INC.
K955165	SYNTHETIC SPONGE	Feb 05, 1996	Substantially Equivalent	IGENICS, INC.
K955321	PROTEC GAUZE SPONGE	Dec 19, 1995	Substantially Equivalent	DERIVADOS DE GASA, S.A. DE C.V.
K953914	KENTEX	Nov 06, 1995	Substantially Equivalent	KENTRON HEALTH CARE, INC.
K953810	FLUFF GAUZE BANDAGE, STERILE & NON-STERILE	Sep 14, 1995	Substantially Equivalent	K. W. GRIFFEN CO.
K953072	MEROCEL VAGINAL PACK	Sep 12, 1995	Substantially Equivalent	MEROCEL CORP.
K953501	ADI STERILE GAUZE SPONGES	Aug 28, 1995	Substantially Equivalent	ASIA DYNAMICS, INC.
K950906	LESINSKI SURGICAL EAR DRESSING	Jun 22, 1995	Substantially Equivalent	MICROTEK MEDICAL, INC.
K950258	HEMO-BARRIER TOURNIQUET	Jun 19, 1995	Substantially Equivalent	HEMO-BARRIER TECHNOLOGIES, INC.
K951660	DYNAREX GAUZE SPONGE	May 09, 1995	Substantially Equivalent	DYNAREX CORP.
K950404	LOCKETT MEDICAL CORP. GAUZE	Apr 17, 1995	Substantially Equivalent	LOCKETT MEDICAL CORP.
K951418	LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE	Apr 14, 1995	Substantially Equivalent	LORONS INTERNATIONAL CORP.
K950462	GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)	Apr 14, 1995	Substantially Equivalent	SPRING INTL., INC.
K945004	2, 3 & 4 BANDADGE COMPRESS	Mar 22, 1995	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K945002	1X6YD, 2X6YD, 4X6YD ROLL BANDAGE	Mar 22, 1995	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K946326	DUTEX GAUZE BANDAGE	Jan 24, 1995	Substantially Equivalent	DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
K945960	LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS	Jan 12, 1995	Substantially Equivalent	LORONS INTERNATIONAL CORP.
K945830	DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)	Jan 11, 1995	Substantially Equivalent	DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
K945021	FLUFF GAUZE SPONGE	Dec 23, 1994	Substantially Equivalent	CLINICAL RESOURCES, INC.
K945020	FLUFF GAUZE SPONGE	Dec 23, 1994	Substantially Equivalent	CLINICAL RESOURCES, INC.
K945019	FLUFF GAUXZE ROLL	Dec 23, 1994	Substantially Equivalent	CLINICAL RESOURCES, INC.
K940765	ISOLYSER	Dec 19, 1994	Substantially Equivalent	THANTEX SPECIALTIES, INC.
K940716	OREX	Dec 19, 1994	Substantially Equivalent	THANTEX SPECIALTIES, INC.
K941099	CLEAN-SORB	Sep 30, 1994	Substantially Equivalent	HOSPITAL SPECIALTY CO.
K943339	GAUZE SPONGE (E.W.A. LTD./VARIOUS)	Aug 23, 1994	Substantially Equivalent	E.W.A., LTD.
K943184	LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S	Aug 03, 1994	Substantially Equivalent	LORONS INTERNATIONAL CORP.
K942824	LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S	Aug 03, 1994	Substantially Equivalent	LORREX HEALTH PRODUCTS
K942692	LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE	Aug 03, 1994	Substantially Equivalent	LORONS INTERNATIONAL CORP.
K942691	LORREX POST OPERATIVE SPONGES	Jul 19, 1994	Substantially Equivalent	LORONS INTERNATIONAL CORP.
K941649	SURGICAL SPONGE	Jun 03, 1994	Substantially Equivalent	INDUSTRIES FOR THE BLIND & VISUALLY IMPAIRED
K942314	LORREX GAUZE SPONGES SPECIALTY	Jun 02, 1994	Substantially Equivalent	LORREX HEALTH PRODUCTS
K941455	STERILE GAUZE PRODUCT LINE	May 20, 1994	Unknown	CUSH MEDICAL PRODUCTS
K942106	SUPER/FLUFF SPONGES	May 19, 1994	Substantially Equivalent	LORREX HEALTH PRODUCTS
K942071	LORREX NON-WOVEN SPONGES NON-STERILE	May 19, 1994	Substantially Equivalent	LORREX HEALTH PRODUCTS
K942070	LORREX COVER SPONGES STERILE2'S AND NON-STERILE	May 19, 1994	Substantially Equivalent	LORREX HEALTH PRODUCTS
K941956	LORREX GAUZE PADS	May 19, 1994	Substantially Equivalent	LORONS INTERNATIONAL CORP.
K941955	LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S	May 12, 1994	Substantially Equivalent	LORREX HEALTH PRODUCTS
K940754	ISOLYER (4X4, 12 PLY)	May 02, 1994	Substantially Equivalent	THANTEX SPECIALTIES, INC.
K940574	TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE	Apr 20, 1994	Substantially Equivalent	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K940904	KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD	Apr 14, 1994	Substantially Equivalent	MEDICAL INSIGHTS, INC.
K940692	PLAIN GAUZE DRESSING	Apr 14, 1994	Substantially Equivalent	MEDTRAX INDUSTRIES, INC.
K935257	MEDICOM NON-WOVEN SPONGES	Apr 14, 1994	Substantially Equivalent	A.R. MEDICOM, INC.
K940901	NON-WOVEN SPONGE	Mar 31, 1994	Substantially Equivalent	MEDICAL INSIGHTS, INC.
K940358	X-LARGE MULTI-FUNCTION TRAUMA DRESSING	Mar 23, 1994	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K940440	DUKAL NON-WOVEN GAUZE	Mar 09, 1994	Substantially Equivalent	DUKAL CORP.
K936216	STERILE GAUZE SPONGES	Mar 09, 1994	Substantially Equivalent	DAV-MAR MEDICAL PRODUCTS, INC.
K940210	VISITEC EYE PAD	Mar 07, 1994	Substantially Equivalent	VISITEC CO.
K940351	EXTRA LARGE COMPRESS DRESSING	Feb 25, 1994	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K940348	TRAUMA PAD 5 X 9	Feb 25, 1994	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K940345	TRIANGULAR BANDAGE	Feb 25, 1994	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K940344	8 X 10 NON-STICK PAD	Feb 25, 1994	Substantially Equivalent	CERTIFIED SAFETY MFG., INC.
K935930	NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING	Feb 03, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K936095	GAUZE SPONGE	Feb 02, 1994	Substantially Equivalent	DUKAL CORP.
K935934	NON ADHERANT BURN PADS	Jan 31, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935911	PACKING SPONGE	Jan 31, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935241	GAUZE DRESSING	Jan 25, 1994	Substantially Equivalent	CHAK TAK (SHEN ZHEN) ENTERPRISES, LTD.
K935941	READY CUT GAUZE GAUZE BOLTS	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935940	GAUZE SPONGE; DRAIN SPONGE	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935939	GAUZE FLUFF	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935938	BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935937	POST OP SPONGE	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935936	CONFORMING ROLL	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935935	BURN GAUZE PADS	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935933	CUSTOM BURN DRESSING	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935932	BURN COMPRESS	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935931	NON-WOVEN SPONGE	Jan 14, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K935942	SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE	Jan 13, 1994	Substantially Equivalent	MCNEIL HEALTHCARE, INC.
K933308	DYNAREX GAUZE SPONGE OR PADS	Dec 22, 1993	Substantially Equivalent	DYNAREX CORP.
K933159	XYZ PADS	Dec 13, 1993	Substantially Equivalent	ASO CORP.
K921983	NU-BREDE PACKING AND DEBRIDEMENT SPONGE	Sep 18, 1992	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K923041	INTESTINAL SPONGES	Aug 10, 1992	Substantially Equivalent	SURGIC AID, INC.
K922055	STERILE AND NON-STERILE GAUZE SPONGES	Aug 10, 1992	Substantially Equivalent	TEAM MFG., INC.
K905068	PTI INTRA-ART (TM) PICK-UP WICKS	Dec 31, 1991	Substantially Equivalent	PIONEERING TECHNOLOGIES, INC.
K912955	EYE PAD	Sep 10, 1991	Substantially Equivalent	CAL WEST TRADING CO.
K910623	GAUZE SPONGES ABSORBENT GAUZE ROLLS	Apr 01, 1991	Substantially Equivalent	LIAONING-USA CORP.
K905136	GAUZE SPONGES, INTERNAL AND EXTERNAL	Mar 06, 1991	Substantially Equivalent	AMERICAN HEALTHCARE CORP.
K897180	MEDI-SURE, MEDI-SORB	Aug 01, 1990	Substantially Equivalent	GULF COAST MEDICAL, INC.
K896801	LAP SPONGE	Dec 27, 1989	Substantially Equivalent	WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
K895865	SERENE WRAP	Dec 27, 1989	Substantially Equivalent	BYRON MEDICAL
K896490	CURITY(R) DISPOSABLE LAPAROTOMY SPONGES	Dec 13, 1989	Substantially Equivalent	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K895086	GAUZE SPONGE	Oct 23, 1989	Substantially Equivalent	KEILEI INTL., INC.
K894505	COTOLIN DRAIN SPONGE AND DRESSING SPONGE	Sep 15, 1989	Substantially Equivalent	JAMES RIVER CORP.
K893902	4 X 4 STERILE GAUZE SPONGE TRAY	Jul 14, 1989	Substantially Equivalent	MUMTAZ I. MALIK
K891460	NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE	Apr 17, 1989	Substantially Equivalent for Some Indications	SMITH & NEPHEW UNITED, INC.
K890770	STERILE LAPAROTOMY SPONGES	Mar 14, 1989	Substantially Equivalent	CYPRESS MEDICAL PRODUCTS, LTD.
K890727	NON-STERILE, BULK GAUZE SPONGES	Mar 10, 1989	Substantially Equivalent	CYPRESS MEDICAL PRODUCTS, LTD.
K885143	ABSORBENT GAUZE ROLL	Feb 10, 1989	Substantially Equivalent	SMITH & NEPHEW, INC.
K885142	GAUZE SWABS, NON-STERILE	Jan 24, 1989	Substantially Equivalent	SMITH & NEPHEW, INC.
K884826	GAUZE SPONGE	Dec 22, 1988	Substantially Equivalent	MEDICAL ACTION INDUSTRIES, INC.
K882021	PRO-FECT LAPAROTOMY SPONGES	Aug 26, 1988	Substantially Equivalent	NETWORK TRADING CORP.
K882712	STICK SPONGE	Aug 03, 1988	Substantially Equivalent	BIOSEAL
K882711	GAUZE SPONGE 12PLY	Aug 03, 1988	Substantially Equivalent	BIOSEAL
K882710	INTESTINAL SPONGES	Aug 03, 1988	Substantially Equivalent	BIOSEAL
K882530	TAPE STRUNG TONSIL SPONGE	Jul 18, 1988	Substantially Equivalent	ORMED MFG., INC.
K882529	BUTCHER STRUNG TONSIL SPONGE	Jul 18, 1988	Substantially Equivalent	ORMED MFG., INC.
K882528	CYLINDRICAL SPONGE	Jul 18, 1988	Substantially Equivalent	ORMED MFG., INC.
K882527	GAUZE SPONGE	Jul 18, 1988	Substantially Equivalent	ORMED MFG., INC.
K881395	GAUZE AND LAP SPONGES -STERILE & NON-STERILE	Apr 28, 1988	Substantially Equivalent	A PLUS INTERNATIONAL, INC
K880208	INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION	Apr 12, 1988	Substantially Equivalent	DRESSER ARGUS, INC.
K881222	JOHNSON & JOHNSON FLUFF SPONGE	Mar 28, 1988	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K880911	BLUNT SPONGE	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880910	ROUND STICK SPONGES	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880909	TRACHEOTOMY SPONGES	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880907	TRIANGLE SPONGE	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880854	STRUNG ABSORBENT BALLS	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880853	CHERRY SPONGE	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880852	ROSEBUD DISSECTORS	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K880851	FLAT STICK SPONGE	Mar 17, 1988	Substantially Equivalent	ORMED MFG., INC.
K874551	ENVINET(TM)	Jan 22, 1988	Substantially Equivalent for Some Indications	MARION LABORATORIES, INC.
K872572	PHARMANET (TM)	Jan 14, 1988	Substantially Equivalent for Some Indications	PHARMACIA, INC.
K874067	GUAZE SPONGES	Dec 14, 1987	Substantially Equivalent	INTERPRO INTL., INC.
K874065	LAPAROTOMY SPONGES	Nov 04, 1987	Substantially Equivalent	INTERPRO INTL., INC.
K873523	PLAIN DRY GAUZE	Oct 09, 1987	Substantially Equivalent	ABSORBENT COTTON CO., INC.
K873831	EAR AND EYE SPONGES	Oct 05, 1987	Substantially Equivalent	ORMED MFG., INC.
K872759	AQUATULLE FINE MESH NON-ADHERING DRESSING	Sep 04, 1987	Substantially Equivalent for Some Indications	SMITH & NEPHEW, INC.
K872808	CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8	Aug 04, 1987	Substantially Equivalent	AMERICAN SILK SUTURES, INC.
K872806	STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG	Aug 04, 1987	Substantially Equivalent	AMERICAN SILK SUTURES, INC.
K871917	FRASTEC DRY GAUZE BANDAGE	Jun 16, 1987	Substantially Equivalent for Some Indications	FRAASS SURVIVAL SYSTEMS, INC.
K871916	FRASTEC DRY BURN DRESSING	Jun 16, 1987	Substantially Equivalent for Some Indications	FRAASS SURVIVAL SYSTEMS, INC.
K871438	BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52	May 06, 1987	Substantially Equivalent	FRAASS SURVIVAL SYSTEMS, INC.
K871005	18X36,36X36,18X72,24X72 GAUZE COMPRESS	Mar 31, 1987	Substantially Equivalent	ADVANTAGE CREDIT SERVICES, INC.
K871002	1X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZE	Mar 31, 1987	Substantially Equivalent	ADVANTAGE CREDIT SERVICES, INC.
K870993	2, 3 AND 4 BANDAGE COMPRESS	Mar 31, 1987	Substantially Equivalent	ADVANTAGE CREDIT SERVICES, INC.
K870314	WHITE PLUME GAUZE SPONGE	Feb 24, 1987	Substantially Equivalent	CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP.
K870308	WHITE PLUME ABSORBENT GAUZE	Feb 24, 1987	Substantially Equivalent	CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP.
K865097	AIMED GAUZE SPONGE	Jan 20, 1987	Substantially Equivalent	KOR-MEDICAL INDUSTRIES, LTD.
K865095	ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES	Jan 20, 1987	Substantially Equivalent	KOR-MEDICAL INDUSTRIES, LTD.
K864298	ZENEX MEDICAL, INC. GAUZE SPONGES	Dec 04, 1986	Substantially Equivalent	ZENEX MEDICAL, INC.
K864175	SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES	Nov 05, 1986	Substantially Equivalent	FRAASS SURVIVAL SYSTEMS, INC.
K863932	GAUZE, ABSORBENT, STERILE, COMPRESSED	Oct 24, 1986	Substantially Equivalent	FRAASS SURVIVAL SYSTEMS, INC.
K863870	GAUZE, NONABSORBABLE, NON-MEDICATED (INTERNAL)	Oct 24, 1986	Substantially Equivalent	MED-TEX, INC.
K863761	2X2 SPONGES, NON-STERILE, COTTON FILLED	Oct 24, 1986	Substantially Equivalent	THE MEDICAL GROUP, INC.
K863760	2X2 SPONGES, NON-STERILE	Oct 24, 1986	Substantially Equivalent	THE MEDICAL GROUP, INC.
K863850	DRESSING, FIRST AID, FIELD, VARIOUS SIZES	Oct 14, 1986	Substantially Equivalent	FRAASS SURVIVAL SYSTEMS, INC.
K863737	SPONGES STERILE TWIN PAKT AND SINGLES	Oct 14, 1986	Substantially Equivalent	HERMITAGE HOSPITAL PRODUCTS, INC.
K863714	BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES	Oct 14, 1986	Substantially Equivalent	FRAASS SURVIVAL SYSTEMS, INC.
K863713	BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES	Oct 14, 1986	Substantially Equivalent	FRAASS SURVIVAL SYSTEMS, INC.
K862126	STERILE LAPAROTOMY GAUZE SPONGE	Jun 19, 1986	Substantially Equivalent	ANAGO, INC.
K861446	S1 ORAL PACKING	May 06, 1986	Substantially Equivalent	SURGICAL SPECIALTIES, INC.
K861445	S1 CAVITY PACKING	May 06, 1986	Substantially Equivalent	SURGICAL SPECIALTIES, INC.
K861444	S1 NASAL PACKING	May 06, 1986	Substantially Equivalent	SURGICAL SPECIALTIES, INC.
K861443	S1 VAGINAL PACKING	May 06, 1986	Substantially Equivalent	SURGICAL SPECIALTIES, INC.
K861308	ACCUPAC CUSTOM PACK KERLIX SQUARES	May 02, 1986	Substantially Equivalent	GENEVA LABORATORIES, INC.
K861215	GAUZE SPONGES USP TYPE VII	Apr 17, 1986	Substantially Equivalent	SELOMAS, INC.
K861154	ALBA HEALTH CARE PLAIN PACKING STRIP	Apr 15, 1986	Substantially Equivalent	ALBA HEALTH CARE
K854432	FALKON STRETCH	Nov 22, 1985	Substantially Equivalent	G.B.F. INDUSTRIES, INC.
K852412	NON-ADHERENT PAD	Jul 29, 1985	Substantially Equivalent	AMERICAN WHITE CROSS, INC.
K852857	4 X 4' GAUZE PAD	Jul 26, 1985	Substantially Equivalent	CORNELIA DAMSKY, INC.
K852202	STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE	Jun 26, 1985	Substantially Equivalent	ORMED MFG., INC.
K852265	NON-STERILE GAUZE ROLLER BANDAGES	Jun 18, 1985	Substantially Equivalent	LEONARD JOSEPH CO.
K844726	GAUZE SPONGE 4X4X12 PLY	Apr 01, 1985	Substantially Equivalent	APPLIED MEDICAL
K844702	GAUZE ASORBABLE	Apr 01, 1985	Substantially Equivalent	MEDICON, INC.
K844677	APPLIED GAUZE SPONGE 2X2X12	Apr 01, 1985	Substantially Equivalent	APPLIED MEDICAL
K844676	APPLIED GAUZE SPONGE 4X4X8	Apr 01, 1985	Substantially Equivalent	APPLIED MEDICAL
K844675	APPLIED GAUZE SPONGE 3X3X12	Apr 01, 1985	Substantially Equivalent	APPLIED MEDICAL
K844674	APPLIED GAUZE SPONGE 2X2X8 PLY	Apr 01, 1985	Substantially Equivalent	APPLIED MEDICAL
K844673	APPLIED GAUZE SPONGE 4X4X16 PLY	Apr 01, 1985	Substantially Equivalent	APPLIED MEDICAL
K844573	ABSORBABLE GAUZE PRODUCTS	Mar 05, 1985	Substantially Equivalent	MEDICON, INC.
K850093	PANAMEDIC GAUZE SPONGES	Feb 21, 1985	Substantially Equivalent	GENERAL ELECTRIC TRADING CO.
K843783	WET PACK	Dec 19, 1984	Substantially Equivalent	E.M. ADAMS
K843782	DRY TRAY	Dec 13, 1984	Substantially Equivalent	E.M. ADAMS
K833867	PAREMA K BAND NON-STERILE	Jan 27, 1984	Substantially Equivalent	MARK ONE HEALTHCARE PRODUCTS
K831917	VILENE COTTON GAUZE II	Sep 26, 1983	Substantially Equivalent	HALL-TECH
K832174	GAUZE SPONGE NON-STERILE	Aug 12, 1983	Substantially Equivalent	SUDRECA SURGICAL DRESSINGS, INC.
K832173	GAUZE SPONGE STERILE	Aug 12, 1983	Substantially Equivalent	SUDRECA SURGICAL DRESSINGS, INC.
K832214	GAUZE CONVERSION CLASS I-NON-STERILE	Jul 26, 1983	Substantially Equivalent	WINN HIRSCH & ASSOC.
K832213	GAUZE CONVERSION CLASS II STERILE	Jul 26, 1983	Substantially Equivalent	WINN HIRSCH & ASSOC.
K831806	SUTURE KITS STERILIZED W/GAMA RADIATION	Jun 29, 1983	Substantially Equivalent	SOUTH MOUNTAIN MEDICAL
K831183	GAUZE SPONGE STERILE SPONGE	Jun 08, 1983	Substantially Equivalent	DEN MED, INC.
K831182	GAUZE SPONGE-NON-STERILE SPONGE	Jun 08, 1983	Substantially Equivalent	DEN MED, INC.
K830268	FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN	Jun 08, 1983	Substantially Equivalent	RITMED, INC.
K830267	FLORET SPECIAL GAUZE SPONGES	Jun 08, 1983	Substantially Equivalent	RITMED, INC.
K830266	FLORET KITTNER OR K DISSECTOR	Jun 08, 1983	Substantially Equivalent	RITMED, INC.
K830261	FLORET STRUNG GAUZE SPONGES	Jun 08, 1983	Substantially Equivalent	RITMED, INC.
K830264	FLORET TONSIL & ADENOID SPONGES	Jun 03, 1983	Substantially Equivalent	RITMED, INC.
K830271	LAPET & LAPWALL LAPAROTOMY SPONGES	Jun 02, 1983	Substantially Equivalent	RITMED, INC.
K830269	FLORET NEURO SPONGE	Jun 02, 1983	Substantially Equivalent	RITMED, INC.
K830278	FLORET GAUZE PACKING	Mar 29, 1983	Substantially Equivalent	RITMED, INC.
K830265	FLORET DRAIN/TRACHEOTOMY SPONGE	Mar 29, 1983	Substantially Equivalent	RITMED, INC.
K830274	FLORET PEANUT SPONGE/STICK & GAUZE PREP	Mar 08, 1983	Substantially Equivalent	RITMED, INC.
K823058	DOSOMETRIC RELEASE STERILIZATION	Dec 09, 1982	Substantially Equivalent	STAN-PAK ENT.
K823485	SURE SNIP	Dec 03, 1982	Substantially Equivalent	SOUTH MOUNTAIN MEDICAL
K821150	NU-GAUZE SPONGE	Aug 27, 1982	Substantially Equivalent	JOHNSON & JOHNSON PROFESSIONALS, INC.
K821701	RAPIDO-LASTIC IN STERILE FORM	Jul 22, 1982	Substantially Equivalent	CONCO MEDICAL CO.
K820195	OR SPECIALTIES VAGINAL PACK	Mar 05, 1982	Substantially Equivalent	HOWARD MEDICAL CO.
K820107	GUAZE SPONGES, PLAIN	Feb 12, 1982	Substantially Equivalent	STAN-PAK ENT.
K820106	X-RAY GUAZE SPONGES	Feb 12, 1982	Substantially Equivalent	STAN-PAK ENT.
K813296	CONVERTORS STERILE DISP. LAP SPONGE II	Dec 29, 1981	Substantially Equivalent	AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K812736	SOFTCARE BARRIER WET DRESSING	Nov 06, 1981	Substantially Equivalent	THE KENDAL CO.
K812572	GAUZE SPONGES	Nov 02, 1981	Substantially Equivalent	WORLDWIDE SURGICAL GAUZE
K811951	DRESSING CHANGE TRAYS & STERILE SPONGES	Oct 16, 1981	Substantially Equivalent	O.R. SPECIALTIES, INC.
K810801	DENTMED V-PACKS	May 27, 1981	Substantially Equivalent	UNIV. OF BRISTOL DENTAL SCHOOL
K810200	OPTIPORE SCRUB SPONGE	Feb 13, 1981	Substantially Equivalent	BIO SYNTEC
K803172	GAUZE SPONGES	Jan 15, 1981	Substantially Equivalent	WORLDWIDE SURGICAL GAUZE
K802863	GAUZE SPONGES	Dec 11, 1980	Substantially Equivalent	ABCO DEALERS, INC.
K802862	GAUZE PADS STERILE SINGLES	Dec 11, 1980	Substantially Equivalent	ABCO DEALERS, INC.
K802861	COMBINATION PADS STERILE SINGLES	Dec 11, 1980	Substantially Equivalent	ABCO DEALERS, INC.
K802860	POST OP. SPONGES STERILE	Dec 11, 1980	Substantially Equivalent	ABCO DEALERS, INC.
K802504	SPONGE SURGICAL GUAZE RADIOPAQUE	Nov 12, 1980	Substantially Equivalent	BARNHARDT MFG. CO.
K802388	MAJOR DRESSING TRAY-MILFORD HOSP.	Nov 12, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K802387	MINOR DRESSING TRAY-MILFORD HOSP.	Nov 12, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K802383	CUSTOM DRESSING TRAY/CARDINAL CUSHING	Nov 12, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K802022	STERILE GUAZE SWABS CAT.#301-420	Sep 16, 1980	Substantially Equivalent	POLLAK (INTL.), LTD.
K802010	GUAZE SWABS CAT.#251-300 (SIZE & PLY)	Sep 16, 1980	Substantially Equivalent	POLLAK (INTL.), LTD.
K802005	ABSORBENT PAD CAT.#729, 732, 730, 731	Sep 16, 1980	Substantially Equivalent	POLLAK (INTL.), LTD.
K801999	GUAZE BALLS CAT.#601-720	Sep 16, 1980	Substantially Equivalent	POLLAK (INTL.), LTD.
K800082	STORZ SUPER SORB MICRO EYE SPONGE	Feb 05, 1980	Substantially Equivalent	STORZ INSTRUMENT CO.
K800021	NON ADHERANT NEUROLOGICAL SPONGES	Jan 17, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K800020	NON ADHERANT WOUND BANDAGES	Jan 17, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792628	STERILIZATION PROCESS/VAGINAL SPONGE	Jan 11, 1980	Substantially Equivalent	PROCTER & GAMBLE MFG. CO.
K792618	TRACHEOTOMY SPONGE, NON-WOVEN DELNET	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792617	TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792616	TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPE	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792615	CELLULOSE TRACHE SPONGE	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792614	TRACHOETOMY SPONGE, NON-ADHERENT CELL	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792613	TRACHEOTOMY SPONGE, NON-ADHERENT	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792612	TRACHEOTOMY SPONGE, W/NON-WOVEN NYLON	Jan 09, 1980	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K792431	VAGINAL PACKING	Dec 27, 1979	Substantially Equivalent	AMERICAN MEDICAL DISPOSABLE, INC.
K791872	LAP SPONGES	Nov 13, 1979	Substantially Equivalent	CARWILD CORP.
K791871	NEUROLOGICAL SPONGES (PATTIES)	Nov 05, 1979	Substantially Equivalent	CARWILD CORP.
K791888	CATHETER CARE KIT REORDER 7940&7941	Oct 17, 1979	Substantially Equivalent	ASCEP, INC.
K790631	STERAID SURGICAL DRESSING	Jul 30, 1979	Substantially Equivalent	CORDA INTL. HOLDINGS, INC.
K790467	SURGICAL EYE SPONGE	Mar 26, 1979	Substantially Equivalent	MEDTECH INTL., INC.
K781985	BURN PAD, DRY, STERILE	Dec 07, 1978	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K781420	SPECIALTY SPONGES	Oct 03, 1978	Substantially Equivalent	IPCO CORP.
K781322	STERILE WET DRESSING PACK	Aug 17, 1978	Substantially Equivalent	W.G. WHITNEY CORP.
K780818	LAPAROTOMY SPONGE	Jun 22, 1978	Substantially Equivalent	QUALTEX, INC.
K780806	LAPOROTOMY SPONGE	Jun 22, 1978	Substantially Equivalent	ABCO DEALERS, INC.
K772089	LAPAROTOMY SPOGNE	Nov 11, 1977	Substantially Equivalent	GENERAL MEDICAL CO.
K771531	LAPAROTOMY SPONGES	Sep 06, 1977	Substantially Equivalent	SURGILITE INTL., INC.
K770889	BURN DRESSING KIT	Jul 11, 1977	Substantially Equivalent	THE OWENBY CO.
K770446	SPONGES, LAPAROTOMY	Jun 15, 1977	Substantially Equivalent	WALPAK CO.
K761034	SURGEX SURGICAL SPONGE	Jan 05, 1977	Substantially Equivalent	CONVERTORS
K761037	INTERSORB LAPAROTOMY SPONGE	Dec 29, 1976	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K760113	SPONGE, LAPAROTOMY GAUZE	Jul 15, 1976	Substantially Equivalent	PARKE-DAVIS CO.

FEI Numbers

This FDA classification entry is associated with 63 FEI numbers. Click on an entry to view related FDA registrations.

1000112877: 433 registrations

1000112968: 424 registrations

1000123222: 187 registrations

1000136478: 184 registrations

1000137528: 104 registrations

1000158435: 10 registrations

1000159144: 12 registrations

1000208624: 172 registrations

1000219637: 355 registrations

1000305719: 10 registrations

1000306431: 841 registrations

1000512168: 447 registrations

1018120: 23 registrations

1043214: 577 registrations

1047843: 371 registrations

1048735: 291 registrations

1219313: 44 registrations

1220477: 911 registrations

1417592: 699 registrations

1527821: 344 registrations

1921846: 275 registrations

1928237: 782 registrations

2024311: 106 registrations

2027062: 136 registrations

2083545: 10 registrations

2242656: 35 registrations

2245304: 497 registrations

2246552: 325 registrations

2648727: 162 registrations

3000215273: 514 registrations

3000268902: 58 registrations

3001124136: 59 registrations

3001236237: 9 registrations

3001236905: 677 registrations

3002806830: 41 registrations

3002807170: 54 registrations

3002807308: 31 registrations

3002808274: 17 registrations

3003040625: 290 registrations

3003259710: 42 registrations

3003418325: 774 registrations

3003636207: 28 registrations

3004605321: 89 registrations

3004950768: 38 registrations

3005011024: 409 registrations

3005663073: 7 registrations

3005747797: 800 registrations

3008851420: 6 registrations

3008875470: 111 registrations

3010041511: 587 registrations

3010155661: 185 registrations

3010452421: 69 registrations

3010605677: 176 registrations

3011089435: 43 registrations

3011862887: 36 registrations

3013176080: 546 registrations

3013502418: 16 registrations

3014421917: 283 registrations

3015207155: 583 registrations

3015781786: 4 registrations

3018094310: 1198 registrations

3019543072: 9 registrations

3035366890: 587 registrations

Registration Numbers

This FDA classification entry is associated with 63 registration numbers. Click on an entry to view related FDA registrations.

1018120: 23 registrations

1043214: 577 registrations

1047843: 371 registrations

1048735: 291 registrations

1054241: 433 registrations

1055236: 424 registrations

1058584: 355 registrations

1060680: 172 registrations

1061124: 447 registrations

1123071: 187 registrations

1219071: 12 registrations

1219313: 44 registrations

1220477: 911 registrations

1223924: 10 registrations

1225532: 9 registrations

1319660: 184 registrations