Cleared Traditional

K041511 - TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K041511 is an FDA 510(k) clearance for TRULENE NON-ABSORBABLE POLYPROPYLENE SU..., manufactured by Sutures India Private Limited. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K041511 · 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
361d
Days
Class 2
Risk

K041511 is an FDA 510(k) clearance for the TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Sutures India Private Limited (Bangalore, IN). The FDA issued a Cleared decision on June 3, 2005 after a review of 361 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 878.5010 - 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 - K041511

510(k) Number K041511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date June 03, 2005
Days to Decision 361 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
246d slower than avg
Panel avg: 115d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 84
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K041511.
COROLENE
K052701 · Peters Surgical · Dec 2005
OPTIMIZED BARB DESIGN
K052962 · Surgical Specialties Corp · Dec 2005
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
K052373 · Quill Medical, Inc. · Sep 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
POLYPROPILENE SURGICAL SUTURES
K043330 · Demetech Corp. · May 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
K050548 · Surgical Specialties Corp · Apr 2005
K041511 · TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
Download PDF FDA Summary Sutures India Private…