Product code GAM
- Device name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4493
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P840051S008 | MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE | Davis & Geck, Inc. | 1996-11-15 |
| P840051S007 | MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE | Davis & Geck, Inc. | 1996-01-11 |
| P840051S006 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. | 1992-03-24 |
| P840051S005 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. | 1991-10-17 |
| P840051S004 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. | 1991-03-29 |
| P840051S003 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. | 1989-06-07 |
| N16881S011 | DEXON | Davis & Geck, Inc. | 1987-11-30 |
| N18387S012 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1987-06-18 |
| P840051S001 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. | 1987-06-05 |
| N16881S010 | DEXON | Davis & Geck, Inc. | 1987-06-05 |
| N16881S009 | DEXON | Davis & Geck, Inc. | 1987-05-19 |
| N18387S011 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1986-12-03 |
| N16881S008 | DEXON | Davis & Geck, Inc. | 1986-07-07 |
| N18387S007 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1984-05-02 |
| N18387S009 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1984-03-27 |
| N18387S010 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1983-11-23 |
| N18387S008 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1983-06-07 |
| N18387S006 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1982-07-21 |
| N18387S005 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1982-07-14 |
| N18387S003 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1982-05-21 |
| N18387S002 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1982-04-05 |
| N18387S001 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1982-04-05 |
| N18387S004 | PDS(TM) SUTURE (CLEAR) | ETHICON, Inc. | 1982-03-15 |
| N16881S003 | DEXON POLYGLYCOLIC ACID SUTURES, SYNTHETIC | Davis & Geck, Inc. | 1982-03-03 |
| N16881S006 | DEXON | Davis & Geck, Inc. | 1981-12-04 |
| N16881S005 | DEXON | Davis & Geck, Inc. | 1981-09-01 |
| N16881S002 | DEXON POLYGLYCOLIC ACID ABSORBABLE SURGICAL SUTURE | Davis & Geck, Inc. | 1981-07-20 |
| N16881S004 | DEXON | Davis & Geck, Inc. | 1981-07-15 |
| N16881S001 | DEXON | Davis & Geck, Inc. | 1981-01-06 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2026-02-06 |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2025-12-22 |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 2025-12-16 |
| 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 |
| K233265 | Monotime and Optime R | Peters Surgical | 2024-10-11 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024-07-12 |
| K221527 | StitchKit | Origami Surgical Inc . | 2023-02-14 |
| K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022-11-15 |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | 2022-08-05 |
| K211792 | StitchKit | Origami Surgical Inc . | 2021-07-16 |
| K202950 | StitchKit COMBO | Origami Surgical | 2021-02-23 |
| K201996 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2020-12-21 |
| K200392 | REXSIN | Sm Eng Co., Ltd. | 2020-07-07 |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | 2020-03-27 |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2019-12-18 |
| 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 |
| K183004 | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 |
| K183001 | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | ETHICON, Inc. | 2018-09-28 |
| K181320 | Caprolon | Resorba Medical GmbH | 2018-09-18 |
| K180625 | Rondek PGA Suture (Beige or Violet) | Rk Manufacturing Corporation | 2018-05-10 |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | 2018-05-04 |
| K173779 | REXMONO, PDREX | Sm Eng Co., Ltd. | 2018-03-12 |
| K173043 | Holycon Synthetic Absorbable Sutures | Nantong Holycon Medical Devices Co., Ltd. | 2017-12-14 |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2017-10-23 |
| K170166 | CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture | Cpt Sutures Co., Ltd. | 2017-09-29 |
| 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 - A... | M/s. Meril Endo Surgery Private Limited. | 2017-09-28 |
| K163676 | Silhouette InstaLift | Silhouette Lift, Inc. | 2017-06-16 |
| K171494 | TroClose1200, TroClose1200 Cannula | Gordian Surgical, Ltd. | 2017-06-15 |
| K170661 | Novosyn Quick Absorbable Suture | Aesculap, Inc. | 2017-06-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809766324892 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326476 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326452 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326438 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326414 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326391 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326315 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326292 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326179 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326094 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326070 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326056 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766326032 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766325899 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766325875 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324878 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324854 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324830 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324793 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324755 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324731 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324717 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324694 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324670 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324656 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324595 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324571 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324557 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 08809766324533 | V-Loc 90 Delta | Samyang Holdings Corporation | 2023-05-31 |
| 07757093005377 | SUTUMED | Unilene S.A.C. | 2023-01-06 |