Cleared Traditional

K042075 - QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

K042075 is an FDA 510(k) clearance for QUILL SYNTHETIC ABSORBABLE BARBED SUTURE, manufactured by Quill Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K042075 · 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
Oct 2004
Decision
85d
Days
Class 2
Risk

K042075 is an FDA 510(k) clearance for the QUILL SYNTHETIC ABSORBABLE BARBED SUTURE. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Quill Medical, Inc. (Westbury, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042075

510(k) Number K042075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date October 26, 2004
Days to Decision 85 days
Submission Type Traditional
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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 66
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K042075.
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
K051609 · Quill Medical, Inc. · Aug 2005
UNICRYL M
K042285 · United Medical Industries Co. , Ltd. · Dec 2004
BLUE ORTHOCORD SUTURE
K043298 · Depuy Mitek · Dec 2004
POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
K041048 · Internacional Farmaceutica, S.A. DE C.V. · Jun 2004
ORTHOCORD SUTURE
K040004 · Depuy Mitek · Apr 2004
MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
K031216 · Aesculap · Jul 2003
K042075 · QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
Download PDF FDA Summary Quill Medical, Inc.