Cleared Traditional

COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED (K962480) - FDA 510(k) Clearance

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

K962480 · Ethicon, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
37d
Days
Class 2
Risk

K962480 is an FDA 510(k) clearance for the COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, .... Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 2, 1996 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K962480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date August 02, 1996
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 147
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