Cleared Abbreviated

K042367 - NYLON THREADED NEEDLE

K042367 is an FDA 510(k) clearance for NYLON THREADED NEEDLE, manufactured by Aros Surgical Instruments Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Abbreviated 510(k) pathway after a 44-day FDA review.

K042367 · Aros Surgical Instruments Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
44d
Days
Class 2
Risk

K042367 is an FDA 510(k) clearance for the NYLON THREADED NEEDLE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Aros Surgical Instruments Corp. (Irvine, US). The FDA issued a Cleared decision on October 14, 2004 after a review of 44 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.

View all Aros Surgical Instruments Corp. devices

FDA 510(k) Submission Details - K042367

510(k) Number K042367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date October 14, 2004
Days to Decision 44 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
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 29
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K042367.
RiverLon (Nylon) Suture
K152795 · Riverpoint Medical · Oct 2015
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000
MICRINS MICROSURGICAL SUTURE
K993970 · Micrins Surgical, Inc. · Mar 2000
SUTRALON NYLON SUTURES
K994176 · Visionary Medical Supplies, Inc. · Feb 2000