Silk Sutures-Revised Labeling

Q: What is the product code of K926168?

The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.

FDA 510(k) K926168 · Look, Inc.

Substantially Equivalent

510(k) numberK926168

Submission

Device name: Silk Sutures-Revised Labeling
Applicant: Look, Inc.
Ada, OK, US
Received: December 1, 1992
Decision date: December 17, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GAR – Suture, Nonabsorbable, Synthetic, Polyamide
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.5020
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code GAR

510(k)	Device	Applicant	Decision
K261484	Tissue Approximation SystemGAR · Special	Tas Medical, Inc.	06/03/2026SE
K220980	Tissue Approximation System (TAS)GAR · Traditional	Tas Medical, Inc.	07/05/2023SE
K212888	Golnit Nylon Monofilament SutureGAR · Abbreviated	Antarma, LLC Dba Golnit Sutures	03/31/2022SE
K212603	Non Absorbable Surgical Nylon SutureGAR · Traditional	Shandong Haidike Medical Product Co., Ltd.	12/22/2021SE
K192420	Crownjun Nylon SutureGAR · Traditional	Kono Seisakusho Co., Ltd.	05/29/2020SE
K161633	Rexlon, RexsilGAR · Traditional	Sm Eng Co., Ltd.	03/02/2017SE
K151165	Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional	Aesculap, Inc.	02/17/2016SE
K152795	RiverLon (Nylon) SutureGAR · Special	Riverpoint Medical	10/28/2015SE
K123034	Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional	Unilene Sac	05/28/2013SE
K081366	Kumar T-Anchors Hernia SetGAR · Traditional	Nashville Surgical Instruments	07/15/2008SE

More from Nashville Surgical Instruments

510(k)	Device	Decision
K943949	Polyviolene Surgicl SutureGAT · Traditional	11/10/1994SN
K933686	Look Inc. 316L Stainless Steel Surgical SutureGAQ · Traditional	12/23/1993SE
K926586	Revised Labeling for Chromic and Plain Gut SuturesGAL · Traditional	12/22/1993SE
K926588	Revised Labeling for Polypropylene SutureGAW · Traditional	12/17/1993SE
K926587	Revised Labeling for Nylon Suture (Polyamide)GAR · Traditional	12/17/1993SE
K926167	Polyviolene Suture-Revised LabelingGAT · Traditional	12/17/1993SE
K913530	Look ViscodissectorHQC · Traditional	10/21/1991SE
K903029	Sterile Black Monofilament Nylon Non-Absor. SutureGAR · Traditional	10/25/1990SE
K903584	Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional	10/11/1990SE
K904054	Polyviolene(Tm) SutureGAS · Traditional	10/03/1990SE

Questions and answers

When was Silk Sutures-Revised Labeling cleared by the FDA?

Silk Sutures-Revised Labeling (K926168) received a 510(k) decision of Substantially Equivalent on December 17, 1993, 381 days after the submission was received.

What is the product code of K926168?

The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.