FDA Product Code
FDA Product Code GDY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4450
510(k) Clearances — 111 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972634 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K960236 | CPR LAP SPONGES | Custom Pack Reliability | 1996-03-28 | Traditional | PDF ↗ |
| K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | Stryker Corp. | 1996-02-22 | Traditional | PDF ↗ |
| K955322 | PROTEC X-RAY DETECTABLE GAUZE SPONGE | Derivados DE Gasa, S.A. DE C.V. | 1995-12-19 | Traditional | PDF ↗ |
| K953830 | KENSORB | Kentron Health Care, Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K953057 | CYLINDRICAL SPONGE | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K953060 | ROSEBUD DISSECTOR | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K953059 | KITTNER DISSECTOR | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K953087 | CHERRY PIT DISSECTOR | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K953062 | CHERRY DISSECTOR | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K953088 | TRIANGULAR SPONGES | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES | Medical Perspectives Corp. | 1995-09-14 | Traditional | PDF ↗ |
| K951911 | GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Commercial Resources New Mexico, Ltd. | 1995-06-21 | Traditional | PDF ↗ |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K950659 | ULTRACELL RETRACTOR COVERS | Ultracell Medical Technologies, Inc. | 1995-04-13 | Traditional | PDF ↗ |
| K945866 | CYLINDRICAL SPONGE | Lorrex Health Products | 1994-12-28 | Traditional | PDF ↗ |
| K945333 | KITTNER DISSECTOR | Lorrex Health Products | 1994-12-28 | Traditional | PDF ↗ |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Lorrex Health Products | 1994-12-28 | Traditional | PDF ↗ |
| K945335 | CHERRY DISSECTOR | Lorrex Health Products | 1994-12-28 | Traditional | PDF ↗ |
| K945606 | TRIANGULAR SPONGES | Lorrex Health Products | 1994-12-28 | Traditional | PDF ↗ |
| K944879 | GAUZE SPONGES | Clinical Resources, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K940764 | OREX | Thantex Specialties, Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K940766 | OREX (18X18 X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K940767 | OREX (12X12 X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K945332 | ROSEBUD DISSECTOR | Lorrex Health Products | 1994-12-05 | Traditional | PDF ↗ |
| K945336 | PEANUT DISSECTOR | Lorrex Health Products | 1994-12-05 | Traditional | PDF ↗ |
| K945334 | CHERRY PIT DISSECTOR | Lorrex Health Products | 1994-12-05 | Traditional | PDF ↗ |
| K940436 | SPONGE, LAPAROTOMY, VARIOUS SIZE | Shawnee Products, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K942366 | LORREX GAUZE SPONGES, X-RAY DETECTABLE | Lorrex Health Products | 1994-05-27 | Traditional | PDF ↗ |
| K941344 | LAP SPONGE PRODUCT LINE | Cush Medical Products | 1994-05-12 | Traditional | PDF ↗ |
| K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES | Cush Medical Products | 1994-05-12 | Traditional | PDF ↗ |
| K940763 | ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K940762 | ISOLYSER (18X18 X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K940757 | ISOLYSER (4X18) X-RAY DETECTABLE | Thantex Specialties, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K940756 | ISOLYSER (X-RAY DETECTABLE) | Thantex Specialties, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K941217 | DUPAQUE SPONGE | Dumex Medical Surgical Products, Ltd. | 1994-04-21 | Traditional | PDF ↗ |
| K934971 | STERILE LAPAROTOMY SPONGES | Medsurg Industries, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K935883 | NEUROLOGICAL SPONGES | Mcneil Healthcare, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K935993 | SURGICAL SPONGE X-RAY DETECTABLE | Mcneil Healthcare, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K935882 | TONSIL SPONGES | Mcneil Healthcare, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K935910 | X-RAY PACKING SPONGE | Mcneil Healthcare, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K935881 | SPECIALTY SPONGES | Mcneil Healthcare, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K932846 | TENCEL X-RAY DETECTABLE SPONGES/LAP PADS | Courtaulds Fibers, Inc. | 1993-12-09 | Traditional | PDF ↗ |
| K922054 | STERILE GAUZE SPONGES X-RAY DETECTABLE | Team Mfg., Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K913303 | LAP SPONGES, MODIFIED | Carwild Corp. | 1992-08-06 | Traditional | PDF ↗ |
| K920356 | SURGICAL SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K920355 | SPECIALTY SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K913302 | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED | Carwild Corp. | 1992-07-23 | Traditional | PDF ↗ |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Icn Pharmaceuticals, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913794 | SIMPEX INC. SURGICAL DRESSING | Simpex, Inc. | 1991-11-20 | Traditional | PDF ↗ |
| K914083 | ICAN K DISSECTOR SPONGES | Icn Pharmaceuticals, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K905135 | LAPAROTOMY SPONGES | American Healthcare Corp. | 1991-03-06 | Traditional | PDF ↗ |
| K903358 | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE | Advance Medical Designs, Inc. | 1990-11-29 | Traditional | PDF ↗ |
| K895372 | X-RAY DETECTABLE GAUZE SPONGE | Keilei Intl., Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K894984 | MASCOT LAB SPONGE | Mascot, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K884790 | QUALTEX NEUROLOK SURGICAL SPONGE | Deroyal Industries, Inc. | 1988-12-09 | Traditional | PDF ↗ |
| K882707 | GAUZE PACKING, X-RAY DETECTABLE | Bioseal | 1988-08-03 | Traditional | PDF ↗ |
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE | Bioseal | 1988-08-03 | Traditional | PDF ↗ |
| K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING | Bioseal | 1988-08-03 | Traditional | PDF ↗ |
| K873391 | MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 | Ormed Mfg., Inc. | 1987-09-11 | Traditional | PDF ↗ |
| K872807 | NON-WOVEN TRACHEOTOMY SPONGE | American Silk Sutures, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K872809 | GAUZE CHERRY SPONGE | American Silk Sutures, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K864529 | LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 | Elof Hansson, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K863089 | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 | Lifestream Int'L, Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K854714 | X-RAY DETECTABLE COTTON BALLS | American Silk Sutures, Inc. | 1985-12-17 | Traditional | PDF ↗ |
| K853742 | GAUZE SPONGE | South Mountain Medical | 1985-10-08 | Traditional | PDF ↗ |
| K842572 | GAUZE & LAB SPONGES STERILE & NON | Ulti-Med Intl., Inc. | 1984-08-15 | Traditional | PDF ↗ |
| K840541 | NEURO SPONGE | Surgicot, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K833626 | FLORET FOAM PREP SPONGE | Ritmed, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K831914 | STRUNG NEURO SPONGE PATTIES-X-RAY- | Ormed Mfg., Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K831913 | COLOR-EZE PRE-WASHED LAP SPONGES | Ormed Mfg., Inc. | 1983-09-26 | Traditional | PDF ↗ |
| K832172 | GAUZE SPONGE X-RAY DETECTABLE- | Sudreca Surgical Dressings, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Winn Hirsch & Assoc. | 1983-03-17 | Traditional | PDF ↗ |
| K830260 | FLORET VAGINAL PACKING/TAMPONS | Ritmed, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON | American Medical Disposable, Inc. | 1983-02-23 | Traditional | PDF ↗ |
| K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE | American Medical Disposable, Inc. | 1983-02-23 | Traditional | PDF ↗ |
| K823671 | NO-GAUZE LAPAROTOMY SPONGE | Surgilite Intl., Inc. | 1983-01-09 | Traditional | PDF ↗ |
| K822623 | LAPAROTOMY SPONGE | Hermitage Hospital Products, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K813286 | PRE-PACK TENS | Cunningham Woodland, Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K813595 | PARKE-DAVIS AEGIS ABOSRBENT SPONGES | Deseret Medical, Inc. | 1982-01-18 | Traditional | PDF ↗ |
| K812391 | NEUROSPONGES | Winn Hirsch & Assoc. | 1981-11-24 | Traditional | PDF ↗ |
| K812390 | NEUROSPONGE PADDIE | Winn Hirsch & Assoc. | 1981-11-24 | Traditional | PDF ↗ |
| K812018 | X-RAY DETECTABLE THREAD | Isramed, Inc. | 1981-11-20 | Traditional | PDF ↗ |
| K812017 | X-RAY DETECTABLE BAND | Isramed, Inc. | 1981-11-20 | Traditional | PDF ↗ |
| K812831 | SURGICAL DRESSINGS | Foreign Trade Zone of Wisconsin | 1981-11-06 | Traditional | PDF ↗ |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | Medspec Corp. | 1981-11-02 | Traditional | PDF ↗ |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | Medspec Corp. | 1981-11-02 | Traditional | PDF ↗ |
| K812651 | X-RAY DETECTABLE LAP SPONGES | Procter & Gamble Mfg. Co. | 1981-10-20 | Traditional | PDF ↗ |
| K812554 | TOMAC STERILE DISP. LAP SPONGE | American Convertors Div., American Pharmaseal | 1981-09-24 | Traditional | PDF ↗ |
| K811632 | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) | Robert I. Chien & Assoc., Inc. | 1981-09-11 | Traditional | PDF ↗ |
| K811769 | LAPAROTOMY PADS | South Mountain Medical | 1981-08-07 | Traditional | PDF ↗ |
| K810184 | LAPAROTOMY SPONGE | Medical Action Industries, Inc. | 1981-02-04 | Traditional | PDF ↗ |
| K803188 | GAUZE SPONGES | Abco Dealers, Inc. | 1981-01-15 | Traditional | PDF ↗ |
| K802982 | GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. | Stanford Laboratories | 1980-12-19 | Traditional | PDF ↗ |
| K802798 | OPRATEX ABDOMINAL PAD | Secol Co. | 1980-12-11 | Traditional | PDF ↗ |
| K802060 | STERILE TONSIL SPONGES | Medspec Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K801768 | CONTAIN X-RAY DETECTABLE LAP SPONGE | The Buckeye Cellulose Corp. | 1980-08-20 | Traditional | PDF ↗ |
| K800281 | MEDSPEC PACKING GAUZE | Medspec Corp. | 1980-03-12 | Traditional | PDF ↗ |
Product code GDY · Class I · General, Plastic Surgery. Data: openFDA.