Rexsin

Q: When was Rexsin cleared by the FDA?

Rexsin (K200392) received a 510(k) decision of Substantially Equivalent on July 7, 2020, 140 days after the submission was received.

Q: What is the product code of K200392?

The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.

FDA 510(k) K200392 · Sm Eng Co., Ltd.

Substantially Equivalent

510(k) numberK200392

Submission

Device name: Rexsin
Applicant: Sm Eng Co., Ltd.
Sasang-Gu, KR
Received: February 18, 2020
Decision date: July 7, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4493
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code GAM

510(k)	Device	Applicant	Decision
K253394	Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional	ETHICON, Inc.	06/25/2026SE
K253530	Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional	Medtronic	05/28/2026SE
K253852	MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional	ETHICON, Inc.	02/06/2026SE
K252743	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional	ETHICON, Inc.	12/22/2025SE
K253620	TroClose 1200GAM · Special	Gordian Surgical, Ltd.	12/16/2025SE
K252820	PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special	Internacional Farmacéutica S.A DE C.V	10/03/2025SE
K233265	Monotime and Optime RGAM · Abbreviated	Peters Surgical	10/11/2024SE
K232372	Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated	Peters Surgical	07/12/2024SE
K221527	StitchKitGAM · Traditional	Origami Surgical Inc .	02/14/2023SE
K221744	STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional	ETHICON, Inc.	11/15/2022SE

More from ETHICON, Inc.

510(k)	Device	Decision
K173747	RexleneGAW · Traditional	12/21/2018SE
K173779	Rexmono, PdrexGAM · Traditional	03/12/2018SE
K161633	Rexlon, RexsilGAR · Traditional	03/02/2017SE
K161629	CrylrexGAM · Traditional	02/10/2017SE

Questions and answers

When was Rexsin cleared by the FDA?

Rexsin (K200392) received a 510(k) decision of Substantially Equivalent on July 7, 2020, 140 days after the submission was received.

What is the product code of K200392?

The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.