Cleared Traditional

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE (K041510) - FDA 510(k) Clearance

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

K041510 · Sutures India Private Limited · General & Plastic Surgery device
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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.

View all Sutures India Private Limited devices

Submission Details

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
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 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 11
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K041510.
Crownjun Nylon Suture
K192420 · Kono Seisakusho Co., Ltd. · May 2020
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · Aesculap, Inc. · Feb 2016
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · Aesculap, Inc. · Mar 1999
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · United States Surgical, A Division of Tyco Healthc · Jan 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · United States Surgical, A Division of Tyco Healthc · Jan 1991