Cleared Traditional

NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE (K041512) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041512 · Sutures India Private Limited · General & Plastic Surgery device
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Jun 2005
Decision
360d
Days
Class 2
Risk

K041512 is an FDA 510(k) clearance for the NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 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 878.5000 - 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.

View all Sutures India Private Limited devices

Submission Details

510(k) Number K041512 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
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.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 73
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K041512.
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · Smith & Nephew, Inc. · Sep 2007
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc. · Oct 2005
ARTHREX SUTURE GRAFTING KIT
K041553 · Arthrex, Inc. · Dec 2004
ARTHREX FIBERWIRE WITH SILK
K041589 · Arthrex, Inc. · Aug 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc. · Jun 2004