Panels › General, Plastic Surgery › Product code GAM · Class 2
Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation 878.4493
6510(k)s in 12 months (150 all time)
2recalls in 12 months (130 all time)
124recalls that name a 510(k)
Top companies in GAM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2003 | K032698 | COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE Coapt Systems, Inc. | GAM |
| Oct 22, 2003 | K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, Inc. | GAM |
| May 29, 2003 | K031286 | SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. | GAM |
| Jan 17, 2003 | K023710 | VISORB SWIFT Cp Medical | GAM |
| Dec 19, 2002 | K022715 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE ETHICON, Inc. | GAM |
| Nov 19, 2002 | K021767 | ASSUFIL Assut Europe S.P.A. | GAM |
| Sep 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, Inc. | GAM |
| Sep 10, 2002 | K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. Arc Medical Supplies (Beijing) Co, Ltd. | GAM |
| Jan 28, 2002 | K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED Surgical Specialties Corp | GAM |
| Jan 8, 2002 | K013671 | L-25 ABSORBABLE SURIGCAL SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Dec 19, 2001 | K013177 | MULTITAK SUTURE SNAP SYSTEM Bonutti Research, Inc. | GAM |
| Aug 1, 2001 | K011372 | AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. | GAM |
| Jun 29, 2001 | K011375 | AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. | GAM |
| May 18, 2001 | K010672 | MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE Gramsmed, LLC | GAM |
| May 11, 2001 | K002639 | BIOKNOTLESS ANCHOR Mitek Products | GAM |
| Mar 13, 2001 | K003017 | GRAMSORB SYNTHETIC ABSORBABLE SUTURE Gramsmed, LLC | GAM |
| Aug 10, 2000 | K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) Cp Medical | GAM |
| Mar 30, 2000 | K000037 | MONOFILAMENT BIOSYN SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Feb 9, 2000 | K994001 | POLYGLYCOLIC ACID Trading Consultants and Distributors Intl., Inc. | GAM |
| Sep 3, 1999 | K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAM |
| Jun 22, 1999 | K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAM |
| Jun 4, 1999 | K984374 | SURGISORB Samyang Corp. | GAM |
| May 27, 1999 | K990432 | SURGISORB Sutures , Ltd., GB | GAM |
| Apr 1, 1999 | K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Jun 25, 1998 | K981935 | POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| May 18, 1998 | K980610 | DEXON RAPID (DEXON R) Davis & Geck, Inc. | GAM |
| May 11, 1998 | K980704 | SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. | GAM |
| Feb 13, 1998 | K974299 | PANACRYL ETHICON, Inc. | GAM |
| Aug 14, 1997 | K972566 | DEXON VIOLET Davis & Geck, Inc. | GAM |
| May 13, 1997 | K971208 | MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS Medline Industries, Inc. | GAM |
| May 5, 1997 | K970863 | MODIFIED USSC* POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Apr 25, 1997 | K970317 | MODIFIED E-PACK PROCEDURE KIT ETHICON, Inc. | GAM |
| Feb 12, 1997 | K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. Lukens Medical Corp. | GAM |
| Dec 16, 1996 | K964345 | ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED ETHICON, Inc. | GAM |
| Oct 8, 1996 | K963253 | SYNTHETIC ABSORBABLE SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Aug 2, 1996 | K962480 | COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED ETHICON, Inc. | GAM |
| Jul 16, 1996 | K961997 | USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Oct 18, 1995 | K953869 | POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Aug 21, 1995 | K951520 | USSC POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Aug 21, 1995 | K945285 | USSC MONOFILAMENT POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Jun 15, 1995 | K946271 | VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT ETHICON, Inc. | GAM |
| Jun 5, 1995 | K951352 | DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE Davis & Geck, Inc. | GAM |
| May 19, 1995 | K944937 | SYNTHETIC ABSORBABLE SUTURE Johnson & Johnson International | GAM |
| Jan 18, 1995 | K944110 | VICRYL RAPIDE SUTURE ETHICON, Inc. | GAM |
| Jan 7, 1994 | K930772 | ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE ETHICON, Inc. | GAM |
| Jan 7, 1994 | K930588 | DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID Davis & Geck, Inc. | GAM |
| Dec 17, 1993 | K930360 | SUTURES ETHICON, Inc. | GAM |
| Nov 17, 1993 | K930746 | SYNTHETIC ABSORBABLE SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
| Mar 23, 1992 | K915835 | COATED VICRYL* II ETHICON, Inc. | GAM |
| Mar 14, 1991 | K905482 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE Pfizer Hospital Products Group, Inc. | GAM |
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