Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4493](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4493) → GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid # GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid _General, Plastic Surgery · 21 CFR 878.4493 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM ## Overview - **Product Code:** GAM - **Device Name:** Suture, Absorbable, Synthetic, Polyglycolic Acid - **Regulation:** [21 CFR 878.4493](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4493) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K253852.md) | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | Feb 6, 2026 | SESE | | [K252743](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K252743.md) | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | Dec 22, 2025 | SESE | | [K253620](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K253620.md) | TroClose 1200 | Gordian Surgical, Ltd. | Dec 16, 2025 | SESE | | [K252820](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K252820.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K233265.md) | Monotime and Optime R | Peters Surgical | Oct 11, 2024 | SESE | | [K232372](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K232372.md) | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | Jul 12, 2024 | SESE | | [K221527](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K221527.md) | StitchKit | Origami Surgical Inc . | Feb 14, 2023 | SESE | | [K221744](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K221744.md) | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | Nov 15, 2022 | SESE | | [K212810](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K212810.md) | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | Aug 5, 2022 | SESE | | [K211792](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K211792.md) | StitchKit | Origami Surgical Inc . | Jul 16, 2021 | SESE | | [K202950](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K202950.md) | StitchKit COMBO | Origami Surgical | Feb 23, 2021 | SESE | | [K201996](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K201996.md) | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | Dec 21, 2020 | SESE | | [K200392](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K200392.md) | REXSIN | Sm Eng Co., Ltd. | Jul 7, 2020 | SESE | | [K200140](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K200140.md) | Silhouette Instalift | Silhouette Lift, Inc. | Mar 27, 2020 | SESE | | [K192580](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K192580.md) | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | Dec 18, 2019 | SESE | | [K183183](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K183183.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K183004.md) | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | Jan 28, 2019 | SESE | | [K183001](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K183001.md) | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | Jan 28, 2019 | SESE | | [K181652](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K181652.md) | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | ETHICON, Inc. | Sep 28, 2018 | SESE | | [K181320](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K181320.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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