Cleared Traditional

TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE (K041515) - FDA 510(k) Clearance

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

K041515 · Sutures India Private Limited · General & Plastic Surgery device
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Apr 2005
Decision
305d
Days
Class 2
Risk

K041515 is an FDA 510(k) clearance for the TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Sutures India Private Limited (Bangalore, IN). The FDA issued a Cleared decision on April 8, 2005 after a review of 305 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 878.4493 - 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 K041515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date April 08, 2005
Days to Decision 305 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
190d slower than avg
Panel avg: 115d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 62
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K041515.
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K132580 · Ethicon, Inc. · Feb 2014
AESCULAP NOVOSYN ABSORBABLE SUTURE
K122734 · Aesculap, Inc. · Dec 2012
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc. · Jun 2005
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · Ethicon, Inc. · Dec 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · United States Surgical, A Division of Tyco Healthc · Nov 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K032420 · Ethicon, Inc. · Oct 2003