Product Code: GDY
FDA class 1
21 CFR 878.4450
Gauze/Sponge, Internal, X-Ray Detectable
General, Plastic Surgery
The Gauze/Sponge, Internal, X-Ray Detectable (product code GDY) is a surgical gauze or sponge used inside the body during procedures to absorb blood and fluids, featuring radiopaque material that makes it detectable by X-ray to prevent accidental retention within the patient after surgery. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4450 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
510(k)s
112
FEI Numbers
228
Registration Numbers
228
Unique Applicants
61
Years Active
20
Basic Information
- Product Code
- GDY
- Device Class
- FDA class 1
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 112 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972634 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K960236 | CPR LAP SPONGES | Mar 28, 1996 | Substantially Equivalent | CUSTOM PACK RELIABILITY |
| K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | Feb 22, 1996 | Substantially Equivalent | STRYKER CORP. |
| K955322 | PROTEC X-RAY DETECTABLE GAUZE SPONGE | Dec 19, 1995 | Substantially Equivalent | DERIVADOS DE GASA, S.A. DE C.V. |
| K953830 | KENSORB | Oct 03, 1995 | Substantially Equivalent | KENTRON HEALTH CARE, INC. |
| K953088 | TRIANGULAR SPONGES | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K953087 | CHERRY PIT DISSECTOR | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K953062 | CHERRY DISSECTOR | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K953060 | ROSEBUD DISSECTOR | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K953059 | KITTNER DISSECTOR | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K953057 | CYLINDRICAL SPONGE | Sep 14, 1995 | Substantially Equivalent | MEDICAL PERSPECTIVES CORP. |
| K951911 | GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Jun 21, 1995 | Substantially Equivalent | COMMERCIAL RESOURCES NEW MEXICO, LTD. |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K950659 | ULTRACELL RETRACTOR COVERS | Apr 13, 1995 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K945866 | CYLINDRICAL SPONGE | Dec 28, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K945606 | TRIANGULAR SPONGES | Dec 28, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Dec 28, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K945335 | CHERRY DISSECTOR | Dec 28, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K945333 | KITTNER DISSECTOR | Dec 28, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K944879 | GAUZE SPONGES | Dec 23, 1994 | Substantially Equivalent | CLINICAL RESOURCES, INC. |
| K940767 | OREX (12X12 X-RAY DETECTABLE) | Dec 19, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K940766 | OREX (18X18 X-RAY DETECTABLE) | Dec 19, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K940764 | OREX | Dec 19, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K945336 | PEANUT DISSECTOR | Dec 05, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K945334 | CHERRY PIT DISSECTOR | Dec 05, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K945332 | ROSEBUD DISSECTOR | Dec 05, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K940436 | SPONGE, LAPAROTOMY, VARIOUS SIZE | Jul 26, 1994 | Substantially Equivalent | SHAWNEE PRODUCTS, INC. |
| K942366 | LORREX GAUZE SPONGES, X-RAY DETECTABLE | May 27, 1994 | Substantially Equivalent | LORREX HEALTH PRODUCTS |
| K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES | May 12, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K941344 | LAP SPONGE PRODUCT LINE | May 12, 1994 | Substantially Equivalent | CUSH MEDICAL PRODUCTS |
| K940763 | ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) | May 02, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K940762 | ISOLYSER (18X18 X-RAY DETECTABLE) | May 02, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K940757 | ISOLYSER (4X18) X-RAY DETECTABLE | May 02, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K940756 | ISOLYSER (X-RAY DETECTABLE) | May 02, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K941217 | DUPAQUE SPONGE | Apr 21, 1994 | Substantially Equivalent | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
| K934971 | STERILE LAPAROTOMY SPONGES | Feb 07, 1994 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K935883 | NEUROLOGICAL SPONGES | Feb 03, 1994 | Substantially Equivalent | MCNEIL HEALTHCARE, INC. |
| K935993 | SURGICAL SPONGE X-RAY DETECTABLE | Feb 02, 1994 | Substantially Equivalent | MCNEIL HEALTHCARE, INC. |
| K935910 | X-RAY PACKING SPONGE | Jan 31, 1994 | Substantially Equivalent | MCNEIL HEALTHCARE, INC. |
| K935882 | TONSIL SPONGES | Jan 31, 1994 | Substantially Equivalent | MCNEIL HEALTHCARE, INC. |
| K935881 | SPECIALTY SPONGES | Jan 31, 1994 | Substantially Equivalent | MCNEIL HEALTHCARE, INC. |
| K932846 | TENCEL X-RAY DETECTABLE SPONGES/LAP PADS | Dec 09, 1993 | Substantially Equivalent | COURTAULDS FIBERS, INC. |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Jun 24, 1993 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K922054 | STERILE GAUZE SPONGES X-RAY DETECTABLE | Aug 10, 1992 | Substantially Equivalent | TEAM MFG., INC. |
| K920356 | SURGICAL SPONGES | Aug 06, 1992 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K920355 | SPECIALTY SPONGES | Aug 06, 1992 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K913303 | LAP SPONGES, MODIFIED | Aug 06, 1992 | Substantially Equivalent | CARWILD CORP. |
| K913302 | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED | Jul 23, 1992 | Substantially Equivalent | CARWILD CORP. |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Nov 27, 1991 | Substantially Equivalent | ICN PHARMACEUTICALS, INC. |
| K913794 | SIMPEX INC. SURGICAL DRESSING | Nov 20, 1991 | Substantially Equivalent | SIMPEX, INC. |
| K914083 | ICAN K DISSECTOR SPONGES | Oct 09, 1991 | Substantially Equivalent | ICN PHARMACEUTICALS, INC. |
| K905135 | LAPAROTOMY SPONGES | Mar 06, 1991 | Substantially Equivalent | AMERICAN HEALTHCARE CORP. |
| K903358 | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE | Nov 29, 1990 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K895372 | X-RAY DETECTABLE GAUZE SPONGE | Nov 03, 1989 | Substantially Equivalent | KEILEI INTL., INC. |
| K894984 | MASCOT LAB SPONGE | Sep 05, 1989 | Substantially Equivalent | MASCOT, INC. |
| K884790 | QUALTEX NEUROLOK SURGICAL SPONGE | Dec 09, 1988 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING | Aug 03, 1988 | Substantially Equivalent | BIOSEAL |
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE | Aug 03, 1988 | Substantially Equivalent | BIOSEAL |
| K882707 | GAUZE PACKING, X-RAY DETECTABLE | Aug 03, 1988 | Substantially Equivalent | BIOSEAL |
| K873391 | MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 | Sep 11, 1987 | Substantially Equivalent | ORMED MFG., INC. |
| K872809 | GAUZE CHERRY SPONGE | Aug 04, 1987 | Substantially Equivalent | AMERICAN SILK SUTURES, INC. |
| K872807 | NON-WOVEN TRACHEOTOMY SPONGE | Aug 04, 1987 | Substantially Equivalent | AMERICAN SILK SUTURES, INC. |
| K864529 | LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 | Dec 16, 1986 | Substantially Equivalent | ELOF HANSSON, INC. |
| K863089 | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 | Oct 14, 1986 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K854714 | X-RAY DETECTABLE COTTON BALLS | Dec 17, 1985 | Substantially Equivalent | AMERICAN SILK SUTURES, INC. |
| K853742 | GAUZE SPONGE | Oct 08, 1985 | Substantially Equivalent | SOUTH MOUNTAIN MEDICAL |
| K842572 | GAUZE & LAB SPONGES STERILE & NON | Aug 15, 1984 | Substantially Equivalent | ULTI-MED INTL., INC. |
| K840541 | NEURO SPONGE | Apr 23, 1984 | Substantially Equivalent | SURGICOT, INC. |
| K833626 | FLORET FOAM PREP SPONGE | Feb 17, 1984 | Substantially Equivalent | RITMED, INC. |
| K831914 | STRUNG NEURO SPONGE PATTIES-X-RAY- | Oct 31, 1983 | Substantially Equivalent | ORMED MFG., INC. |
| K831913 | COLOR-EZE PRE-WASHED LAP SPONGES | Sep 26, 1983 | Substantially Equivalent | ORMED MFG., INC. |
| K832172 | GAUZE SPONGE X-RAY DETECTABLE- | Aug 12, 1983 | Substantially Equivalent | SUDRECA SURGICAL DRESSINGS, INC. |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Mar 17, 1983 | Substantially Equivalent | WINN HIRSCH & ASSOC. |
| K830260 | FLORET VAGINAL PACKING/TAMPONS | Mar 17, 1983 | Substantially Equivalent | RITMED, INC. |
| K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON | Feb 23, 1983 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE | Feb 23, 1983 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K823671 | NO-GAUZE LAPAROTOMY SPONGE | Jan 09, 1983 | Substantially Equivalent | SURGILITE INTL., INC. |
| K822623 | LAPAROTOMY SPONGE | Oct 13, 1982 | Substantially Equivalent | HERMITAGE HOSPITAL PRODUCTS, INC. |
| K813286 | PRE-PACK TENS | Jan 22, 1982 | Substantially Equivalent | CUNNINGHAM WOODLAND, INC. |
| K813595 | PARKE-DAVIS AEGIS ABOSRBENT SPONGES | Jan 18, 1982 | Substantially Equivalent | DESERET MEDICAL, INC. |
| K812391 | NEUROSPONGES | Nov 24, 1981 | Substantially Equivalent | WINN HIRSCH & ASSOC. |
| K812390 | NEUROSPONGE PADDIE | Nov 24, 1981 | Substantially Equivalent | WINN HIRSCH & ASSOC. |
| K812018 | X-RAY DETECTABLE THREAD | Nov 20, 1981 | Substantially Equivalent | ISRAMED, INC. |
| K812017 | X-RAY DETECTABLE BAND | Nov 20, 1981 | Substantially Equivalent | ISRAMED, INC. |
| K812831 | SURGICAL DRESSINGS | Nov 06, 1981 | Substantially Equivalent | FOREIGN TRADE ZONE OF WISCONSIN |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | Nov 02, 1981 | Substantially Equivalent | MEDSPEC CORP. |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | Nov 02, 1981 | Substantially Equivalent | MEDSPEC CORP. |
| K812651 | X-RAY DETECTABLE LAP SPONGES | Oct 20, 1981 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K812554 | TOMAC STERILE DISP. LAP SPONGE | Sep 24, 1981 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K811632 | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) | Sep 11, 1981 | Substantially Equivalent | ROBERT I. CHIEN & ASSOC., INC. |
| K811769 | LAPAROTOMY PADS | Aug 07, 1981 | Substantially Equivalent | SOUTH MOUNTAIN MEDICAL |
| K810184 | LAPAROTOMY SPONGE | Feb 04, 1981 | Substantially Equivalent | MEDICAL ACTION INDUSTRIES, INC. |
| K803188 | GAUZE SPONGES | Jan 15, 1981 | Substantially Equivalent | ABCO DEALERS, INC. |
| K802982 | GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. | Dec 19, 1980 | Substantially Equivalent | STANFORD LABORATORIES |
| K802798 | OPRATEX ABDOMINAL PAD | Dec 11, 1980 | Substantially Equivalent | SECOL CO. |
| K802060 | STERILE TONSIL SPONGES | Oct 10, 1980 | Substantially Equivalent | MEDSPEC CORP. |
| K801768 | CONTAIN X-RAY DETECTABLE LAP SPONGE | Aug 20, 1980 | Substantially Equivalent | THE BUCKEYE CELLULOSE CORP. |
| K800281 | MEDSPEC PACKING GAUZE | Mar 12, 1980 | Substantially Equivalent | MEDSPEC CORP. |
| K800102 | STANFORD STERILE LAP SPONGES | Jan 28, 1980 | Substantially Equivalent | LUKENS CORP. |
| K792630 | STERILIZATION PROCESS/X-RAY DETECT. SPG | Jan 11, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K792471 | STANFORD STERILE LAP SPONGES | Dec 20, 1979 | Substantially Equivalent | LUKENS CORP. |
| K790389 | GAUZE & COTTON SPONGES | Mar 26, 1979 | Substantially Equivalent | MEDTECH INTL., INC. |
| K782107 | LAP SPONGE | Feb 16, 1979 | Substantially Equivalent | CARAPACE, INC. |
| K790050 | SPONGES, STANFORD STERILE LAP | Jan 17, 1979 | Substantially Equivalent | STANFORD PROFESSIONAL PRODUCTS |
| K781818 | LAPARATOMY SPONGE | Nov 15, 1978 | Substantially Equivalent | MEDEN MEDICAL SALES DIVISION |
| K780718 | SOF-WICKLAP PAD | Jun 28, 1978 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K780871 | ARTERIAL LINE KIT | Jun 14, 1978 | Substantially Equivalent | ARGON MEDICAL CORP. |
| K771395 | LAPAROTOMY SPONGES, STERILE | Aug 19, 1977 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K770924 | GREEN RADIOPAQUE IN SURG. SPONGES | Aug 10, 1977 | Substantially Equivalent | KENDALL RESEARCH CENTER |
FEI Numbers
This FDA classification entry is associated with 228 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 228 registration numbers. Click on an entry to view related FDA registrations.