Product Code: MGQ FDA unclassified

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Unknown

The hydrogel wound and burn dressing with drug and/or biologic agent carries an unclassified (Class U) FDA designation, meaning its classification has not been formally determined. It combines a hydrogel matrix with an incorporated drug or biologic component to provide moisture management and therapeutic effects in wound and burn management. The product code is MGQ and no regulation number or formal medical specialty has been assigned. It is not implanted and does not sustain life.

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510(k)s

145

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MGQ
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 145 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171879	HylaGuard Moisturizing Cream	Oct 16, 2017	Substantially Equivalent	Founders Science Group, LLC
K083024	HYLATOPIC EMOLLIENT FOAM	Mar 27, 2009	Substantially Equivalent	Collegium Pharmaceutical Incorporated
K041342	IMPRUV A.I. CREAM WOUND AND SKIN EMULSION	Jul 19, 2005	Substantially Equivalent	Stiefel Laboratories, Inc.
K041268	SILVERSITE OR CALGITROL	Sep 20, 2004	Substantially Equivalent	Adri
K040019	SILVERSEAL	Jul 23, 2004	Substantially Equivalent	Noble Fiber Technologies
K040517	TENDERWET ACTIVE	Mar 25, 2004	Substantially Equivalent	Medline Industries, Inc.
K022587	MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS	Aug 22, 2003	Substantially Equivalent	Medtrade Products , Ltd.
K024367	SINCLAIR WOUND AND SKIN EMULSION	Jul 28, 2003	Substantially Equivalent	Sinclair Pharmaceuticals, Ltd.
K024054	XYLOS XCELL ANTIMICROBIAL DRESSING	Mar 07, 2003	Substantially Equivalent	Xylos Corporation
K022584	CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING	Dec 30, 2002	Substantially Equivalent	Cardiotech Intl.
K022995	COLLATEK HYDROGEL	Dec 02, 2002	Substantially Equivalent	Biocore Medical Technologies, Inc.
K013525	CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)	Oct 04, 2002	Substantially Equivalent	Coloplast Corp.
K020325	L.A.M. IPM WOUND GEL	Apr 15, 2002	Substantially Equivalent	L.A.M. Pharmaceutical, Corp.
K011994	ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101	Nov 08, 2001	Substantially Equivalent	Acrymed, Inc.
K010583	AMBU GEL, HYDROGEL BURN DRESSING	May 25, 2001	Substantially Equivalent	Ambu, Inc.
K002666	DIAMOND ALOE VERA, STERILE	Feb 27, 2001	Substantially Equivalent	Medi-Tech Intl. Corp.
K003396	BURN JEL PLUS	Jan 11, 2001	Substantially Equivalent	Water-Jel Technologies, LLC
K002078	BETA GLUCAN GEL (MACROPRO GEL)	Oct 02, 2000	Substantially Equivalent	Brennen Medical, Inc.
K002077	GLUCANPRO CREAM	Oct 02, 2000	Substantially Equivalent	Brennen Medical, Inc.
K002129	FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN	Aug 25, 2000	Substantially Equivalent	Ferris Mfg. Corp.
K000519	GLUCANPRO	May 01, 2000	Substantially Equivalent	Brennen Medical, Inc.
K000518	MACROPRO GEL	May 01, 2000	Substantially Equivalent	Brennen Medical, Inc.
K991755	MEDLINE TENDER WET WOUND DRESSING	Apr 17, 2000	Substantially Equivalent	Medline Industries, Inc.
K992074	MPM REGENECARE WOUND GEL	Dec 23, 1999	Substantially Equivalent	Mpm Medical., Inc.
K993119	STERILE HYDROGEL	Nov 23, 1999	Substantially Equivalent	Dumex Medical Surgical Products, Ltd.
K990180	BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING	Aug 13, 1999	Substantially Equivalent	Nortrade Medical, Inc.
K990179	BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD	Aug 13, 1999	Substantially Equivalent	Nortrade Medical, Inc.
K990178	BURNFREE PAIN RELIEVING GEL, MODEL 4B	Aug 13, 1999	Substantially Equivalent	Nortrade Medical, Inc.
K990440	GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE	Aug 12, 1999	Substantially Equivalent	Gentell
K991202	MODIFICATION TO WOUN'DRES	Jun 04, 1999	Substantially Equivalent	Coloplast Corp.
K990368	DUODERM HYDROACTIVE GEL WOUND DRESSING	Mar 26, 1999	Substantially Equivalent	Convatec, A Bristol-Myers Squibb Co.
K984370	HYPERGEL 20% HYPERTONIC SALINE GEL	Mar 01, 1999	Substantially Equivalent	Molnlycke Health Care, Inc.
K984368	NORMLGEL 0.9% ISOTONIC SALINE GEL	Feb 22, 1999	Substantially Equivalent	Molnlycke Health Care, Inc.
K984413	BIONECT HYDROGEL	Feb 10, 1999	Substantially Equivalent	Fidia Pharmaceutical Corp.
K984267	MODIFICATION OF BIONECT HYDROGEL FOAM	Feb 10, 1999	Substantially Equivalent	Fidia Pharmaceutical Corp.
K984266	MODIFICATION OF BIONECT HYDROGEL SPRAY	Feb 10, 1999	Substantially Equivalent	Fidia Pharmaceutical Corp.
K984264	MODIFICATION OF BIONECT CLEAR HYDROGEL	Feb 10, 1999	Substantially Equivalent	Fidia Pharmaceutical Corp.
K984262	MODIFICATION OF BIONECT HYDROGEL GAUZE PADS	Feb 10, 1999	Substantially Equivalent	Fidia Pharmaceutical Corp.
K984082	BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET	Jan 28, 1999	Substantially Equivalent	Emox 911 CC
K983362	NU-GEL * WOUND DRESSING	Dec 16, 1998	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K982804	SPYROGEL HYDROGEL WOUND AND BURN DRESSING	Dec 16, 1998	Substantially Equivalent for Some Indications	Innovative Technologies (Us), Inc.
K983042	SWEEN WOUN'DRES	Nov 25, 1998	Substantially Equivalent	Coloplast Corp.
K982825	BRENNEN MEDICAL BETA GLUCAN GEL	Nov 06, 1998	Substantially Equivalent	Brennen Medical, Inc.
K982577	NEUFINISH RESURFACING CREAM	Oct 21, 1998	Substantially Equivalent	Neutrogena Corp.
K982306	POLYTUBE	Sep 22, 1998	Substantially Equivalent	Ferris Mfg. Corp.
K973725	BIONECT CLEAR HYDROGEL	Sep 22, 1998	Substantially Equivalent	Fidia Pharmaceutical Corp.
K973724	BIONECT HYDROGEL SPRAY	Sep 22, 1998	Substantially Equivalent	Fidia Pharmaceutical Corp.
K973722	BIONECT HYDROGEL FOAM	Sep 22, 1998	Substantially Equivalent	Fidia Pharmaceutical Corp.
K973721	BIONECT HYDROGEL GAUZE PADS	Sep 22, 1998	Substantially Equivalent	Fidia Pharmaceutical Corp.
K980962	BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO	Jul 29, 1998	Substantially Equivalent	Brennen Medical, Inc.
K980132	PHYTACARE ALGINATE HYDROGEL WOUND DRESSING	Jun 26, 1998	Substantially Equivalent for Some Indications	Phytatek Laboratories, Inc.
K981150	SOLOSITE GEL CONFORMABLE DRESSING	Jun 22, 1998	Substantially Equivalent	Smith & Nephew, Inc.
K974251	X-CELL WOUND DRESSING	Jun 22, 1998	Substantially Equivalent	Xylos Corporation
K980861	DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL	May 20, 1998	Substantially Equivalent	Dumex Medical Surgical Products, Ltd.
K980097	FLEXIGEL-G HYDROGEL WOUND DRESSING	Mar 04, 1998	Substantially Equivalent	Innovative Technologies , Ltd.
K973806	DUODERM HYDROACTIVE GEL	Dec 29, 1997	Substantially Equivalent for Some Indications	Convatec, A Bristol-Myers Squibb Co.
K973693	AQUA PATCH	Dec 18, 1997	Substantially Equivalent for Some Indications	Pci Technology
K971918	AMERIGEL OINTMENT SATURATED WOUND DRESSING	Aug 12, 1997	Substantially Equivalent	Amerx Health Care Corp.
K970153	LAMIN-2 HYDRATING GEL	Jun 05, 1997	Substantially Equivalent	Procyte Corp.
K965143	OSMOCYTE WOUND MANAGER SHEET DRESSING	May 22, 1997	Substantially Equivalent	Procyte Corp.
K970133	AMERIGEL OINTMENT	Apr 14, 1997	Substantially Equivalent for Some Indications	Amerx Health Care Corp.
K970453	B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING	Apr 11, 1997	Substantially Equivalent for Some Indications	B.Braun Medical, Inc.
K970693	ACRYDERM GEL WOUND DRESSING	Mar 21, 1997	Substantially Equivalent for Some Indications	Acrymed, Inc.
K965005	IAMIN IMPREGNATED GAUZE DRESSING	Feb 24, 1997	Substantially Equivalent	Procyte Corp.
K963004	BIONECT CREAM	Feb 12, 1997	Substantially Equivalent for Some Indications	Fidia Pharmaceutical Corp.
K964468	IAMIN WET DRESSING (COPPER-SALINE)	Feb 03, 1997	Substantially Equivalent	Procyte Corp.
K964240	BIAFINE WOUND DRESSING EMULSION	Jan 22, 1997	Substantially Equivalent	Medix Pharmaceuticals Americas, Inc.
K964620	PANOGAUZE NON-WOVEN HYDROGEL DRESSING	Jan 09, 1997	Substantially Equivalent for Some Indications	Sage Pharmaceuticals, Inc.
K962917	MULTIDEX HYDROPHILIC WOUND DRESSING GEL	Dec 16, 1996	Substantially Equivalent for Some Indications	Lange Medical Products, Inc.
K964241	BRENNEN MEDICAL GLUCAN II WOUND DRESSING	Dec 12, 1996	Substantially Equivalent	Brennen Medical, Inc.
K962089	DERMAMEND GEL	Nov 05, 1996	Substantially Equivalent	Dermarx Corp.
K961930	CHONDROPROTEC	Oct 15, 1996	Substantially Equivalent for Some Indications	The Hymed Group Corp.
K962513	DERMAPLEX HYDROGEL WOUND DRESSING	Sep 12, 1996	Substantially Equivalent for Some Indications	Maxxim Medical
K962218	CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG	Sep 12, 1996	Substantially Equivalent for Some Indications	Carrington Laboratories, Inc.
K962851	ACRYNOODLES ABSORBENT WOUND DRESSING	Sep 06, 1996	Substantially Equivalent	Acrymed, Inc.
K962439	DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)	Sep 03, 1996	Substantially Equivalent	Richard Hamer Assoc., Inc.
K960686	HYCOAT	Aug 12, 1996	Substantially Equivalent for Some Indications	The Hymed Group Corp.
K961766	WOUND HYDROGEL & STERILE WOUND HYDROGEL	Jul 15, 1996	Substantially Equivalent for Some Indications	Renaissance Pharmaceutical, Inc.
K961316	WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL	Jul 15, 1996	Substantially Equivalent for Some Indications	Renaissance Pharmaceutical, Inc.
K961758	CARASYN HYDROGEL WOUND PRODUCTS	Jul 11, 1996	Substantially Equivalent for Some Indications	Carrington Laboratories, Inc.
K962160	MPM HYDROGEL DRESSING (NON-STERILE)	Jun 26, 1996	Substantially Equivalent	Mpm Medical., Inc.
K961085	DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING	May 21, 1996	Substantially Equivalent	Debusk Knitting Mills, Div. Deroyal Industries
K961067	BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET	May 16, 1996	Substantially Equivalent	Medtrak Intl., Inc.
K960428	CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)	Mar 21, 1996	Substantially Equivalent for Some Indications	Carrington Laboratories, Inc.
K955400	QUEGEL HYDROPHILIC WOUND DRESSING	Feb 09, 1996	Substantially Equivalent for Some Indications	Questor Pharma, Inc.
K953505	BURNAID BURN FIRST AID DRESSING	Feb 09, 1996	Substantially Equivalent for Some Indications	Rye Pharmaceuticals Pty. , Ltd.
K953853	IAMIN GEL WOUND DRESSING	Feb 05, 1996	Substantially Equivalent for Some Indications	Procyte Corp.
K955575	TECNOL HYDROGEL WOUND DRESSING	Jan 17, 1996	Substantially Equivalent for Some Indications	Tecnol Medical Products, Inc.
K952938	AQUAFLO BTP HYDROGEL WOUND DRESSING	Dec 08, 1995	Substantially Equivalent	Sherwood Medical Co.
K954741	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	Nov 01, 1995	Substantially Equivalent for Some Indications	Derma Sciences, Inc.
K954664	DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING	Nov 01, 1995	Substantially Equivalent for Some Indications	Derma Sciences, Inc.
K954384	WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL	Oct 16, 1995	Substantially Equivalent for Some Indications	Renaissance Pharmaceutical, Inc.
K952775	DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING	Oct 06, 1995	Substantially Equivalent for Some Indications	Deroyal Industries, Inc.
K953669	PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING	Sep 22, 1995	Substantially Equivalent for Some Indications	Marketing Perspectives
K953816	DCURASOL GEL WOUND DRESSING	Aug 28, 1995	Substantially Equivalent for Some Indications	Dpt Laboratories, Ltd.
K953450	CURASOL GEL WOUND DRESSING	Aug 07, 1995	Substantially Equivalent	Dpt Laboratories, Ltd.
K952419	STERIGAUZE GEL DRESSING	Jul 26, 1995	Substantially Equivalent	Acacia Laboratories, Inc.
K952247	BURNSHIELD TRAUMA DRESSING	Jul 26, 1995	Substantially Equivalent	Golightly International Corp.
K952774	MULTIDEX GEL	Jul 24, 1995	Substantially Equivalent	Lange Medical Products, Inc.
K951862	A GEL WOUND DRESSING	Jul 12, 1995	Substantially Equivalent	Polymedica Industries, Inc.
K951861	STERICARE WOUND CARE GEL	Jul 11, 1995	Substantially Equivalent	Acacia Laboratories, Inc.
K952276	MPM HYDROGEL DRESSING	Jun 30, 1995	Substantially Equivalent	Mpm Medical., Inc.
K950934	MPM HYDROGEL DRESSING	May 16, 1995	Substantially Equivalent for Some Indications	Richard Hamer Assoc., Inc.
K945217	HYDROGEL DRESSING	May 12, 1995	Substantially Equivalent for Some Indications	O.R. Resources, Inc.
K951417	CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS	May 10, 1995	Substantially Equivalent	Carrington Laboratories, Inc.
K945005	PANOPLEX HYDROGEL WOUND DRESSING	Mar 24, 1995	Substantially Equivalent	Sage Pharmaceuticals, Inc.
K946031	DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING	Feb 27, 1995	Substantially Equivalent	Wilshire Medical Products
K946030	DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING	Feb 27, 1995	Substantially Equivalent	Wilshire Medical Products
K943910	BIAFINE	Feb 27, 1995	Substantially Equivalent	Laboratoire Medix
K945835	ARGIDENE(TM) GEL	Feb 13, 1995	Substantially Equivalent	Telios Pharmaceuticals, Inc.
K945313	SPARTA HYDROGEL WOUND DRESSING	Jan 12, 1995	Substantially Equivalent	Sparta Surgical Corp.
K944427	CARRASYN FDG	Nov 29, 1994	Substantially Equivalent for Some Indications	Carrington Laboratories, Inc.
K944333	HYDRODERM GEL WOUND DRESSING	Nov 10, 1994	Substantially Equivalent for Some Indications	Wilshire Medical Products
K943728	BURNFREE BURNSOOTHE HYDROGEL	Sep 27, 1994	Substantially Equivalent for Some Indications	Levtrade Intl. (Pty) , Ltd.
K943470	BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS	Sep 27, 1994	Substantially Equivalent for Some Indications	Levtrade Intl. (Pty) , Ltd.
K942419	HYDRO-S WOUND GEL	Aug 05, 1994	Substantially Equivalent	Hymedix Intl., Inc.
K943073	CURAFIL WOUND GEL DRESSING	Jul 26, 1994	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health
K932291	EUTRA GEL FOR WOUND DRESSING	Jul 18, 1994	Substantially Equivalent for Some Indications	Swiss American Products, Inc.
K942798	MPM HYDROGEL	Jul 11, 1994	Substantially Equivalent for Some Indications	Mpm Medical., Inc.
K940409	M-K HYDROGEL DRESSING	Jul 11, 1994	Substantially Equivalent for Some Indications	Mason-Keller Corp.
K941339	STERILE WOUND HYDROGEL DRESSING	Jun 10, 1994	Substantially Equivalent	Renaissance Pharmaceutical, Inc.
K940814	HYDRO-M(TM) WOUND GEL	May 12, 1994	Substantially Equivalent	Kingston Technologies, Inc.
K926353	FLOWGEL(R) TOPICAL WOUND DRESSING	Feb 22, 1994	Substantially Equivalent for Some Indications	Mediventures, Inc.
K935096	BIOLEX IMPREGNATED WOUND DRESSING	Feb 17, 1994	Substantially Equivalent	C.R. Bard, Inc.
K935203	WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL	Jan 18, 1994	Substantially Equivalent	Renaissance Medical, Inc.
K933495	MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS)	Jan 12, 1994	Substantially Equivalent	Marketing Professionals IN Medicine, Inc.
K933817	ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE	Jan 10, 1994	Substantially Equivalent	Renaissance Medical, Inc.
K932973	ROYL-DERM WOUND HYDROGEL DRESSING	Jan 10, 1994	Substantially Equivalent	Renaissance Medical, Inc.
K932101	DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING	Dec 27, 1993	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K934267	DAMOR CREAM SATURATED DRESSING	Dec 07, 1993	Substantially Equivalent	Damor America, Inc.
K933328	DAMOR CREME	Dec 07, 1993	Substantially Equivalent	Damor America, Inc.
K932263	SOLOSITE DERMAL WOUND GEL	Oct 01, 1993	Substantially Equivalent	Smith & Nephew United, Inc.
K930560	MPM HYDROGEL SATURATED DRESSING	Jul 08, 1993	Substantially Equivalent	Mpm Medical., Inc.
K926389	SWEEN WOUND CARE-COLLAGEN WOUND DRESSING	Jul 08, 1993	Substantially Equivalent	Sween Corp.
K920554	KOLD WRAP STERILE BURN DRESSING	Feb 19, 1993	Substantially Equivalent	Kold Products
K922815	ROYL-DERM WOUND HYDROGEL	Oct 28, 1992	Substantially Equivalent	Renaissance Medical, Inc.
K921810	CURASOL(TM) WOUND DRESSING	Jul 23, 1992	Substantially Equivalent	Healthsouth Medical Center
K913344	DERMAGRAN WET DRESSING (ZINC-SALINE)	Jul 14, 1992	Substantially Equivalent	Derma Sciences, Inc.
K914746	DERMAGRAN WET DRESSING	Jun 17, 1992	Substantially Equivalent	Derma Sciences, Inc.
K920642	MICRO-COLL COLLAGEN DERMAL WOUND SPRAY	Apr 29, 1992	Substantially Equivalent	Micro-Collagen Pharmaceutics, Ltd.
K920050	BIOLEX WOUND GEL,	Apr 07, 1992	Substantially Equivalent for Some Indications	Catalina Biomedical Corp.
K915002	STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS	Jan 31, 1992	Substantially Equivalent	Carrington Laboratories, Inc.
K915001	CARRINGTON WOUND DRESSING 4X4(TM)	Jan 31, 1992	Substantially Equivalent	Carrington Laboratories, Inc.
K911550	2ND SKIN MOIST BURN PADS WITH ALOE	Sep 06, 1991	Substantially Equivalent	Spenco Medical Corp.
K912667	DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS	Sep 04, 1991	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons