GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid

Device class

Class II

Regulation 878.4493

Total clearances

2020-03-27 → 2026-06-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4493

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
ETHICON, Inc.	5	3	2026-06-25
Peters Surgical	2	0	2024-10-11
Origami Surgical Inc .	2	0	2023-02-14
Internacional Farmacéutica S.A DE C.V	1	1	2025-10-03
Sm Eng Co., Ltd.	1	0	2020-07-07
Gordian Surgical, Ltd.	1	1	2025-12-16
Silhouette Lift, Inc.	1	0	2020-03-27
Medtronic	1	1	2026-05-28
Origami Surgical	1	0	2021-02-23
Samyang Holdings Corp., Ltd.	1	0	2022-08-05

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
99070	CPT	—	High	Absorbable polyglycolic sutures typically billed as surgical supplies
A2682	HCPCS	—	Medium	HCPCS for surgical supplies/suture materials when tracked separately

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-25	K253394	ETHICON, Inc.	Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
2026-05-28	K253530	Medtronic	Trexon Monofilament Synthetic Absorbable Suture
2026-02-06	K253852	ETHICON, Inc.	MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
2025-12-22	K252743	ETHICON, Inc.	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
2025-12-16	K253620	Gordian Surgical, Ltd.	TroClose 1200
2025-10-03	K252820	Internacional Farmacéutica S.A DE C.V	PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
2024-10-11	K233265	Peters Surgical	Monotime and Optime R
2024-07-12	K232372	Peters Surgical	Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
2023-02-14	K221527	Origami Surgical Inc .	StitchKit
2022-11-15	K221744	ETHICON, Inc.	STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
2022-08-05	K212810	Samyang Holdings Corp., Ltd.	MONOFIX PGCL, knotless wound closure device
2021-07-16	K211792	Origami Surgical Inc .	StitchKit
2021-02-23	K202950	Origami Surgical	StitchKit COMBO
2020-12-21	K201996	ETHICON, Inc.	Monocryl Plus Antibacterial Suture
2020-07-07	K200392	Sm Eng Co., Ltd.	REXSIN
2020-03-27	K200140	Silhouette Lift, Inc.	Silhouette Instalift