Quill Nonabsorbable Nylon Barbed Suture

Q: What is the product code of K052900?

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) K052900 · Quill Medical, Inc.

Substantially Equivalent

510(k) numberK052900

Submission

Device name: Quill Nonabsorbable Nylon Barbed Suture
Applicant: Quill Medical, Inc.
Research Triangle Park, NC, US
Received: October 14, 2005
Decision date: November 28, 2005
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary 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
K052373	Quill Nonabsorbable Polypropylene Barbed SutureGAW · Abbreviated	09/26/2005SE
K051609	Quill Synthetic Absorbable Barbed SutureNEW · Traditional	08/04/2005SE
K042075	Quill Synthetic Absorbable Barbed SutureNEW · Traditional	10/26/2004SE

Questions and answers

When was Quill Nonabsorbable Nylon Barbed Suture cleared by the FDA?

Quill Nonabsorbable Nylon Barbed Suture (K052900) received a 510(k) decision of Substantially Equivalent on November 28, 2005, 45 days after the submission was received.

What is the product code of K052900?

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