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 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263073 | Fast Absorbing PGLA | Riverpoint Medical, LLC | 2026-09-29 | Special | PDF ↗ |
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | 2026-06-25 | Traditional | PDF ↗ |
| K253530 | Trexon Monofilament Synthetic Absorbable Suture | Medtronic | 2026-05-28 | Traditional | PDF ↗ |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | 2025-12-22 | Traditional | PDF ↗ |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 2025-12-16 | Special | PDF ↗ |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmacéutica S.A DE C.V | 2025-10-03 | Special | PDF ↗ |
| K233265 | Monotime and Optime R | Peters Surgical | 2024-10-11 | Abbreviated | PDF ↗ |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024-07-12 | Abbreviated | PDF ↗ |
| K221527 | StitchKit | Origami Surgical Inc . | 2023-02-14 | Traditional | PDF ↗ |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022-11-15 | Traditional | PDF ↗ |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | 2022-08-05 | Traditional | PDF ↗ |
| K211792 | StitchKit | Origami Surgical Inc . | 2021-07-16 | Special | PDF ↗ |
| K202950 | StitchKit COMBO | Origami Surgical | 2021-02-23 | Traditional | PDF ↗ |
| K201996 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2020-12-21 | Traditional | PDF ↗ |
| K200392 | REXSIN | Sm Eng Co., Ltd. | 2020-07-07 | Traditional | PDF ↗ |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | 2020-03-27 | Traditional | PDF ↗ |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2019-12-18 | Traditional | PDF ↗ |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2019-06-27 | Traditional | PDF ↗ |
| K183001 | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 | Traditional | PDF ↗ |
| K183004 | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 | Traditional | PDF ↗ |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | ETHICON, Inc. | 2018-09-28 | Traditional | PDF ↗ |
| K181320 | Caprolon | Resorba Medical GmbH | 2018-09-18 | Traditional | PDF ↗ |
| K180625 | Rondek PGA Suture (Beige or Violet) | Rk Manufacturing Corporation | 2018-05-10 | Traditional | PDF ↗ |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | 2018-05-04 | Traditional | PDF ↗ |
| K173779 | REXMONO, PDREX | Sm Eng Co., Ltd. | 2018-03-12 | Traditional | PDF ↗ |
| K173043 | Holycon Synthetic Absorbable Sutures | Nantong Holycon Medical Devices Co., Ltd. | 2017-12-14 | Traditional | PDF ↗ |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2017-10-23 | Traditional | PDF ↗ |
| K170166 | CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture | Cpt Sutures Co., Ltd. | 2017-09-29 | Traditional | PDF ↗ |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture | M/s. Meril Endo Surgery Private Limited. | 2017-09-28 | Special | PDF ↗ |
| K163676 | Silhouette InstaLift | Silhouette Lift, Inc. | 2017-06-16 | Traditional | PDF ↗ |
| K171494 | TroClose1200, TroClose1200 Cannula | Gordian Surgical, Ltd. | 2017-06-15 | Special | PDF ↗ |
| K170661 | Novosyn Quick Absorbable Suture | Aesculap, Inc. | 2017-06-08 | Traditional | PDF ↗ |
| K161629 | CRYLREX | Sm Eng Co., Ltd. | 2017-02-10 | Traditional | PDF ↗ |
| K160564 | TroClose1200 | Gordian Surgical, Ltd. | 2016-11-17 | Traditional | PDF ↗ |
| K161726 | E-Pack Procedure Kit | ETHICON, Inc. | 2016-07-12 | Special | PDF ↗ |
| K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device | Ethicon, LLC | 2016-06-03 | Traditional | PDF ↗ |
| K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | Resorba Medical GmbH | 2015-11-02 | Traditional | PDF ↗ |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron | M/s. Meril Endo Surgery Private Limited. | 2015-10-14 | Traditional | PDF ↗ |
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015-08-13 | Traditional | PDF ↗ |
| K142061 | SILHOUETTE INSTALIFT | Silhouette Lift, Inc. | 2015-04-24 | Traditional | PDF ↗ |
| K142822 | PLIASURE Polyglycolide Synthetic Absorbable Suture | ETHICON, Inc. | 2015-03-26 | Traditional | PDF ↗ |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Foosin Medical Supplies Inc., Ltd. | 2014-11-14 | Special | PDF ↗ |
| K140039 | POLYCRYL | Aurolab | 2014-09-15 | Traditional | PDF ↗ |
| K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corporation | 2014-07-30 | Special | PDF ↗ |
| K141625 | POLYSYN SURGICAL SUTURE | Surgical Specialties Corp | 2014-07-18 | Special | PDF ↗ |
| K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | Surgical Specialties Corp | 2014-07-11 | Special | PDF ↗ |
| K123940 | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE | Demetech Corp. | 2014-05-30 | Traditional | PDF ↗ |
| K140227 | MONODERM SURGICAL SUTURE | Surgical Specialties Corp | 2014-02-28 | Special | PDF ↗ |
| K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | ETHICON, Inc. | 2014-02-28 | Traditional | PDF ↗ |
| K130737 | SYNTHETIC ABSORBABLE SUTURE | Foosin Medical Supplies Inc., Ltd. | 2014-01-14 | Traditional | PDF ↗ |
| K130735 | SYNTHETIC ABSORBABLE SUTURE | Foosin Medical Supplies Inc., Ltd. | 2014-01-14 | Traditional | PDF ↗ |
| K130083 | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE | Demetech Corp. | 2013-07-17 | Traditional | PDF ↗ |
| K123836 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corp. Dba Angiotech | 2012-12-21 | Special | PDF ↗ |
| K122734 | AESCULAP NOVOSYN ABSORBABLE SUTURE | Aesculap, Inc. | 2012-12-18 | Traditional | PDF ↗ |
| K123409 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corp. Dba Angiotech | 2012-11-20 | Traditional | PDF ↗ |
| K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corp. Dba Angiotech | 2012-10-22 | Traditional | PDF ↗ |
| K120556 | VILET VILET QUICK | Riverpoint Medical | 2012-05-23 | Abbreviated | PDF ↗ |
| 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 | 2011-06-03 | Special | PDF ↗ |
| K102592 | SUTRAZORB | Visionary Medical Supplies, Inc. | 2011-02-03 | Abbreviated | PDF ↗ |
| K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | Surgical Devices, A Division of Tyco Healthcare | 2010-05-10 | Traditional | PDF ↗ |
| K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Surgical Devices, A Division of Tyco Healthcare | 2009-11-12 | Special | PDF ↗ |
| K091087 | MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Surgical Devices, Tyco Healthcare Group LP | 2009-04-22 | Special | PDF ↗ |
| K082662 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Surgical Devices, Tyco Healthcare Group LP | 2009-03-26 | Traditional | PDF ↗ |
| K080412 | ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | 2008-09-04 | Traditional | PDF ↗ |
| K081002 | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | Traditional | PDF ↗ |
| K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | Traditional | PDF ↗ |
| K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 2008-05-23 | Traditional | PDF ↗ |
| K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 2008-05-23 | Traditional | PDF ↗ |
| K073493 | HEPATOSTAT SET | Vygon Corp. | 2008-05-06 | Traditional | PDF ↗ |
| K072645 | UNIGLACTIN | United Medical Industries Co. , Ltd. | 2007-11-07 | Traditional | PDF ↗ |
| K072646 | UNICAPRONE | United Medical Industries Co. , Ltd. | 2007-11-07 | Traditional | PDF ↗ |
| K072644 | UNICRYL QUICK | United Medical Industries Co. , Ltd. | 2007-11-07 | Traditional | PDF ↗ |
| K072229 | MONOSWIFT | Cp Medical | 2007-10-05 | Abbreviated | PDF ↗ |
| K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM | Surgical Specialties Corp | 2007-08-03 | Traditional | PDF ↗ |
| K063536 | POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING | Tyco Healthcare Group | 2007-01-29 | Traditional | PDF ↗ |
| K063462 | NEATSTITCH NEATCLOSE SUTURING DEVICE | Neat Stitch , Ltd. | 2007-01-12 | Traditional | PDF ↗ |
| K061796 | HEPATOSTAT SET, MODEL 760X | Vygon Corp. | 2006-11-02 | Traditional | PDF ↗ |
| K062366 | OPTIME, SINUSORB PGA | Peters Surgical | 2006-10-02 | Traditional | PDF ↗ |
| K060801 | DEKNA-LOK MODEL BP1000V2L | Teleflex Medical | 2006-05-17 | Traditional | PDF ↗ |
| K060828 | MODIFICATION TO ENDOTINE RIBBON | Coapt Systems, Inc. | 2006-04-19 | Special | PDF ↗ |
| K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) | Mani, Inc. | 2006-03-14 | Traditional | PDF ↗ |
| K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE | Surgical Specialties Corp | 2005-11-07 | Traditional | PDF ↗ |
| K051700 | OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR | Medchannel, LLC | 2005-08-15 | Traditional | PDF ↗ |
| K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE | ETHICON, Inc. | 2005-06-29 | Traditional | PDF ↗ |
| K051415 | ENDOTINE RIBBON | Coapt Systems, Inc. | 2005-06-23 | Traditional | PDF ↗ |
| K050771 | LUPINE LOOP | Depuy Mitek, A Johnson & Johnson Company | 2005-04-08 | Special | PDF ↗ |
| K041515 | TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE | Sutures India Private Limited | 2005-04-08 | Traditional | PDF ↗ |
| K043539 | DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES | Demetech Corp. | 2005-04-06 | Traditional | PDF ↗ |
| K050611 | ENDOTINE RIBBON | Coapt Systems, Inc. | 2005-04-06 | Special | PDF ↗ |
| K042288 | UNICRYL | United Medical Industries Co. , Ltd. | 2004-12-27 | Traditional | PDF ↗ |
| K042141 | POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE | Teleflex Medical | 2004-09-28 | Traditional | PDF ↗ |
| K042233 | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE | Depuy Mitek, A Johnson & Johnson Company | 2004-09-28 | Traditional | PDF ↗ |
| K041806 | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP | Depuy Mitek, A Johnson & Johnson Company | 2004-08-03 | Traditional | PDF ↗ |
| K040477 | MONODERM | Surgical Specialties Corp | 2004-05-18 | Traditional | PDF ↗ |
| K040282 | ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID | Internacional Farmaceutica, S.A. DE C.V. | 2004-04-29 | Traditional | PDF ↗ |
| K033762 | SERRALAPG | Serral, S.A. DE C.V. | 2004-03-15 | Traditional | PDF ↗ |
| K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 2003-12-18 | Special | PDF ↗ |
| K032586 | CAPROSYN ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | 2003-11-17 | Abbreviated | PDF ↗ |
| K033115 | ORTHODEK | Teleflex Medical | 2003-11-17 | Traditional | PDF ↗ |
Product code GAM · Class II · General, Plastic Surgery. Data: openFDA.