Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel

Q: What is the product code of K143582?

The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.

FDA 510(k) K143582 · Resorba Medical GmbH

Substantially Equivalent

510(k) numberK143582

Submission

Device name: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel
Applicant: Resorba Medical GmbH
Nuremberg, DE
Received: December 18, 2014
Decision date: October 29, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.5010
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code GAW

510(k)	Device	Applicant	Decision
K253572	STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional	ETHICON, Inc.	03/27/2026SE
K233355	Cypris eXact Suturing SystemGAW · Traditional	Cypris Medical	01/12/2024SE
K230746	Non absorbable Surgical Polypropylene SutureGAW · Traditional	Shandong Haidike Medical Products Co., Ltd.	09/14/2023SE
K221280	VessealGAW · Traditional	Lydus Medical , Ltd.	12/09/2022SE
K211178	DURAMESH Mesh SutureGAW · Traditional	Msi	09/02/2022SE
K192953	APTOS Threads Polypropylene Surgical SuturesGAW · Traditional	Aptos, LLC	08/27/2020SE
K193530	Deklene MAXXGAW · Special	Teleflex Medical	03/19/2020SE
K191299	Silhouette Featherlift / Silhouette LiftGAW · Special	Silhouette Lift, Inc.	06/14/2019SE
K173747	RexleneGAW · Traditional	Sm Eng Co., Ltd.	12/21/2018SE
K180321	Aesculap Optilene Nonabsorbable SutureGAW · Special	Aesculap, Inc.	03/07/2018SE

More from Aesculap, Inc.

510(k)	Device	Decision
K181320	CaprolonGAM · Traditional	09/18/2018SE
K143584	Pga Resorba, Pga Resoquick, GlycolonGAM · Traditional	11/02/2015SE
K141072	SupoleneGAT · Traditional	06/23/2014SE

Questions and answers

When was Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel cleared by the FDA?

Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel (K143582) received a 510(k) decision of Substantially Equivalent on October 29, 2015, 315 days after the submission was received.

What is the product code of K143582?

The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.