GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid
General, Plastic Surgery · 21 CFR 878.4493 · Class 2
Overview
| Product Code | GAM |
|---|---|
| Device Name | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Regulation | 21 CFR 878.4493 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 147)
Showing 20 most recent of 147 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | Feb 6, 2026 | SESE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | Dec 22, 2025 | SESE |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | Dec 16, 2025 | SESE |
| 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 | Oct 3, 2025 | SESE |
| K233265 | Monotime and Optime R | Peters Surgical | Oct 11, 2024 | SESE |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | Jul 12, 2024 | SESE |
| K221527 | StitchKit | Origami Surgical Inc . | Feb 14, 2023 | SESE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | Nov 15, 2022 | SESE |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | Aug 5, 2022 | SESE |
| K211792 | StitchKit | Origami Surgical Inc . | Jul 16, 2021 | SESE |
| K202950 | StitchKit COMBO | Origami Surgical | Feb 23, 2021 | SESE |
| K201996 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | Dec 21, 2020 | SESE |
| K200392 | REXSIN | Sm Eng Co., Ltd. | Jul 7, 2020 | SESE |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | Mar 27, 2020 | SESE |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | Dec 18, 2019 | SESE |
| 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. | Jun 27, 2019 | SESE |
| K183004 | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | Jan 28, 2019 | SESE |
| K183001 | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | Jan 28, 2019 | SESE |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | ETHICON, Inc. | Sep 28, 2018 | SESE |
| K181320 | Caprolon | Resorba Medical GmbH | Sep 18, 2018 | SESE |
Top Applicants
- ETHICON, Inc. — 25 clearances
- United States Surgical, A Division of Tyco Healthc — 12 clearances
- Surgical Specialties Corp — 7 clearances
- Aesculap, Inc. — 7 clearances
- Foosin Medical Supplies Inc., Ltd. — 5 clearances
