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 |
|---|---|---|---|
| Jan 14, 2014 | K130737 | SYNTHETIC ABSORBABLE SUTURE Foosin Medical Supplies Inc., Ltd., CN | GAM |
| Jan 14, 2014 | K130735 | SYNTHETIC ABSORBABLE SUTURE Foosin Medical Supplies Inc., Ltd., CN | GAM |
| Jul 17, 2013 | K130083 | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE Demetech Corp. | GAM |
| Dec 21, 2012 | K123836 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech | GAM |
| Dec 18, 2012 | K122734 | AESCULAP NOVOSYN ABSORBABLE SUTURE Aesculap, Inc. | GAM |
| Nov 20, 2012 | K123409 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech | GAM |
| Oct 22, 2012 | K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech | GAM |
| May 23, 2012 | K120556 | VILET VILET QUICK Riverpoint Medical | GAM |
| Jun 3, 2011 | K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... Covidien, Formerly US Surgical A Divison of Tyco H | GAM |
| Feb 3, 2011 | K102592 | SUTRAZORB Visionary Medical Supplies, Inc. | GAM |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, A Division of Tyco Healthcare | GAM |
| Nov 12, 2009 | K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, A Division of Tyco Healthcare | GAM |
| Apr 22, 2009 | K091087 | MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, Tyco Healthcare Group LP | GAM |
| Mar 26, 2009 | K082662 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, Tyco Healthcare Group LP | GAM |
| Sep 4, 2008 | K080412 | ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) Shanghai Pudong Jinhuan Medical Products Co., Ltd. | GAM |
| Jun 9, 2008 | K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE Sutures India Pvt., Ltd., IN | GAM |
| Jun 9, 2008 | K081002 | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE Sutures India Pvt., Ltd., IN | GAM |
| May 23, 2008 | K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES Internacional Farmaceutica, S.A. DE C.V. | GAM |
| May 23, 2008 | K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES Internacional Farmaceutica, S.A. DE C.V. | GAM |
| May 6, 2008 | K073493 | HEPATOSTAT SET Vygon Corp. | GAM |
| Nov 7, 2007 | K072646 | UNICAPRONE United Medical Industries Co. , Ltd., SA | GAM |
| Nov 7, 2007 | K072645 | UNIGLACTIN United Medical Industries Co. , Ltd., SA | GAM |
| Nov 7, 2007 | K072644 | UNICRYL QUICK United Medical Industries Co. , Ltd., SA | GAM |
| Oct 5, 2007 | K072229 | MONOSWIFT Cp Medical | GAM |
| Aug 3, 2007 | K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM Surgical Specialties Corp | GAM |
| Jan 29, 2007 | K063536 | POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING Tyco Healthcare Group | GAM |
| Jan 12, 2007 | K063462 | NEATSTITCH NEATCLOSE SUTURING DEVICE Neat Stitch , Ltd., IL | GAM |
| Nov 2, 2006 | K061796 | HEPATOSTAT SET, MODEL 760X Vygon Corp. | GAM |
| Oct 2, 2006 | K062366 | OPTIME, SINUSORB PGA Peters Surgical, FR | GAM |
| May 17, 2006 | K060801 | DEKNA-LOK MODEL BP1000V2L Teleflex Medical | GAM |
| Apr 19, 2006 | K060828 | MODIFICATION TO ENDOTINE RIBBON Coapt Systems, Inc. | GAM |
| Mar 14, 2006 | K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) Mani, Inc. | GAM |
| Nov 7, 2005 | K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE Surgical Specialties Corp | GAM |
| Aug 15, 2005 | K051700 | OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR Medchannel, LLC | GAM |
| Jun 29, 2005 | K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE ETHICON, Inc. | GAM |
| Jun 23, 2005 | K051415 | ENDOTINE RIBBON Coapt Systems, Inc. | GAM |
| Apr 8, 2005 | K050771 | LUPINE LOOP Depuy Mitek, A Johnson & Johnson Company | GAM |
| Apr 8, 2005 | K041515 | TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE Sutures India Private Limited, IN | GAM |
| Apr 6, 2005 | K050611 | ENDOTINE RIBBON Coapt Systems, Inc. | GAM |
| Apr 6, 2005 | K043539 | DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES Demetech Corp. | GAM |
| Dec 27, 2004 | K042288 | UNICRYL United Medical Industries Co. , Ltd., SA | GAM |
| Sep 28, 2004 | K042233 | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE Depuy Mitek, A Johnson & Johnson Company | GAM |
| Sep 28, 2004 | K042141 | POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE Teleflex Medical | GAM |
| Aug 3, 2004 | K041806 | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP Depuy Mitek, A Johnson & Johnson Company | GAM |
| May 18, 2004 | K040477 | MONODERM Surgical Specialties Corp | GAM |
| Apr 29, 2004 | K040282 | ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID Internacional Farmaceutica, S.A. DE C.V. | GAM |
| Mar 15, 2004 | K033762 | SERRALAPG Serral, S.A. DE C.V. | GAM |
| Dec 18, 2003 | K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, Inc. | GAM |
| Nov 17, 2003 | K033115 | ORTHODEK Teleflex Medical | GAM |
| Nov 17, 2003 | K032586 | CAPROSYN ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc | GAM |
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