Cleared Traditional

K022715 - COATED VICRYL PLUS ANTIMICROBIAL (POLYG...

K022715 is the FDA 510(k) clearance for COATED VICRYL PLUS ANTIMICROBIAL (POLYG... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAM) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K022715 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 2002
Decision
126d
Days
Class 2
Risk

K022715 is an FDA 510(k) clearance for the COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) 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 December 19, 2002 after a review of 126 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Ethicon, Inc. devices

Submission Details

510(k) Number K022715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2002
Decision Date December 19, 2002
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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 74
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K022715.
ORTHODEK
K033115 · Teleflex Medical · Nov 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K032420 · Ethicon, Inc. · Oct 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · Aesculap, Inc. · May 2003
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · Ethicon, Inc. · Sep 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · United States Surgical, A Division of Tyco Healthc · Jan 2002
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · Aesculap, Inc. · Aug 2001