FDA Product Code
FDA Product Code GAM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4493
510(k) Clearances — 150 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K032698 | COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE | Coapt Systems, Inc. | 2003-10-23 | Traditional | PDF ↗ |
| K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | ETHICON, Inc. | 2003-10-22 | Traditional | PDF ↗ |
| K031286 | SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE | Aesculap, Inc. | 2003-05-29 | Special | PDF ↗ |
| K023710 | VISORB SWIFT | Cp Medical | 2003-01-17 | Traditional | PDF ↗ |
| K022715 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K021767 | ASSUFIL | Assut Europe S.P.A. | 2002-11-19 | Traditional | PDF ↗ |
| K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 2002-09-13 | Traditional | PDF ↗ |
| K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. | Arc Medical Supplies (Beijing) Co, Ltd. | 2002-09-10 | Traditional | PDF ↗ |
| K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED | Surgical Specialties Corp | 2002-01-28 | Traditional | PDF ↗ |
| K013671 | L-25 ABSORBABLE SURIGCAL SUTURE | United States Surgical, A Division of Tyco Healthc | 2002-01-08 | Abbreviated | PDF ↗ |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | Bonutti Research, Inc. | 2001-12-19 | Traditional | PDF ↗ |
| K011372 | AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE | Aesculap, Inc. | 2001-08-01 | Traditional | PDF ↗ |
| K011375 | AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE | Aesculap, Inc. | 2001-06-29 | Traditional | PDF ↗ |
| K010672 | MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE | Gramsmed, LLC | 2001-05-18 | Traditional | PDF ↗ |
| K002639 | BIOKNOTLESS ANCHOR | Mitek Products | 2001-05-11 | Traditional | PDF ↗ |
| K003017 | GRAMSORB SYNTHETIC ABSORBABLE SUTURE | Gramsmed, LLC | 2001-03-13 | Traditional | PDF ↗ |
| K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) | Cp Medical | 2000-08-10 | Traditional | PDF ↗ |
| K000037 | MONOFILAMENT BIOSYN SUTURE | United States Surgical, A Division of Tyco Healthc | 2000-03-30 | Traditional | PDF ↗ |
| K994001 | POLYGLYCOLIC ACID | Trading Consultants and Distributors Intl., Inc. | 2000-02-09 | Traditional | PDF ↗ |
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-09-03 | Traditional | PDF ↗ |
| K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-06-22 | Traditional | PDF ↗ |
| K984374 | SURGISORB | Samyang Corp. | 1999-06-04 | Traditional | PDF ↗ |
| K990432 | SURGISORB | Sutures , Ltd. | 1999-05-27 | Traditional | PDF ↗ |
| K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | 1999-04-01 | Traditional | PDF ↗ |
| K981935 | POLYSORB SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-06-25 | Traditional | PDF ↗ |
| K980610 | DEXON RAPID (DEXON R) | Davis & Geck, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K980704 | SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE | Aesculap, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K974299 | PANACRYL | ETHICON, Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K972566 | DEXON VIOLET | Davis & Geck, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K971208 | MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS | Medline Industries, Inc. | 1997-05-13 | Traditional | PDF ↗ |
| K970863 | MODIFIED USSC* POLYSORB SUTURE | United States Surgical, A Division of Tyco Healthc | 1997-05-05 | Traditional | PDF ↗ |
| K970317 | MODIFIED E-PACK PROCEDURE KIT | ETHICON, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. | Lukens Medical Corp. | 1997-02-12 | Traditional | PDF ↗ |
| K964345 | ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED | ETHICON, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K963253 | SYNTHETIC ABSORBABLE SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1996-10-08 | Traditional | PDF ↗ |
| K962480 | COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED | ETHICON, Inc. | 1996-08-02 | Traditional | PDF ↗ |
| K961997 | USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | 1996-07-16 | Traditional | PDF ↗ |
| K953869 | POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | 1995-10-18 | Traditional | PDF ↗ |
| K951520 | USSC POLYSORB SUTURE | United States Surgical, A Division of Tyco Healthc | 1995-08-21 | Traditional | PDF ↗ |
| K945285 | USSC MONOFILAMENT POLYSORB SUTURE | United States Surgical, A Division of Tyco Healthc | 1995-08-21 | Traditional | PDF ↗ |
| K946271 | VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT | ETHICON, Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K951352 | DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE | Davis & Geck, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K944937 | SYNTHETIC ABSORBABLE SUTURE | Johnson & Johnson International | 1995-05-19 | Traditional | PDF ↗ |
| K944110 | VICRYL RAPIDE SUTURE | ETHICON, Inc. | 1995-01-18 | Traditional | PDF ↗ |
| K930588 | DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID | Davis & Geck, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930772 | ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE | ETHICON, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930360 | SUTURES | ETHICON, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K930746 | SYNTHETIC ABSORBABLE SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1993-11-17 | Traditional | PDF ↗ |
| K915835 | COATED VICRYL* II | ETHICON, Inc. | 1992-03-23 | Traditional | PDF ↗ |
| K905482 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE | Pfizer Hospital Products Group, Inc. | 1991-03-14 | Traditional | PDF ↗ |
Product code GAM · Class II · General, Plastic Surgery. Data: openFDA.