Cleared Traditional

K041510 - TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE

K041510 is an FDA 510(k) clearance for TRULON NON-ABSORBABLE POLYAMIDE SURGICA..., manufactured by Sutures India Private Limited. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K041510 · Sutures India Private Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
360d
Days
Class 2
Risk

K041510 is an FDA 510(k) clearance for the TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Sutures India Private Limited (Bangalore, IN). The FDA issued a Cleared decision on June 2, 2005 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K041510

510(k) Number K041510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date June 02, 2005
Days to Decision 360 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
245d slower than avg
Panel avg: 115d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K041510.
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
QUILL NONABSORBABLE NYLON BARBED SUTURE
K052900 · Quill Medical, Inc. · Nov 2005
ARTELON SURGICAL SUTURE
K052482 · Artimplant AB · Oct 2005
UNIMIDE
K042284 · United Medical Industries Co. , Ltd. · Dec 2004
NYLON THREADED NEEDLE
K042367 · Aros Surgical Instruments Corp. · Oct 2004
ARTELON SURGICAL SUTURE
K032160 · Artimplant AB · Nov 2003
K041510 · TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
Download PDF FDA Summary Sutures India Private…