Cleared Abbreviated

K052900 - QUILL NONABSORBABLE NYLON BARBED SUTURE

K052900 is an FDA 510(k) clearance for QUILL NONABSORBABLE NYLON BARBED SUTURE, manufactured by Quill Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Abbreviated 510(k) pathway after a 45-day FDA review.

K052900 · Quill Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
45d
Days
Class 2
Risk

K052900 is an FDA 510(k) clearance for the QUILL NONABSORBABLE NYLON BARBED SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Quill Medical, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on November 28, 2005 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K052900

510(k) Number K052900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date November 28, 2005
Days to Decision 45 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Standards-based clearance path.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K052900.
FSSB NYLON SURGICAL SUTURES
K060471 · Fssb Chirurgische Nadeln GmbH · Jul 2006
MANI NEEDLE & SUTURE PACK (NYLON)
K053637 · Mani, Inc. · May 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
ARTELON SURGICAL SUTURE
K052482 · Artimplant AB · Oct 2005
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
K041510 · Sutures India Private Limited · Jun 2005
UNIMIDE
K042284 · United Medical Industries Co. , Ltd. · Dec 2004
K052900 · QUILL NONABSORBABLE NYLON BARBED SUTURE
Download PDF FDA Summary Quill Medical, Inc.