Cleared Traditional

K181652 - Coated Vicryl Plus Antibacterial (Polyg...

K181652 is the FDA 510(k) clearance for Coated Vicryl Plus Antibacterial (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 98-day FDA review.

K181652 · Ethicon, Inc. · General & Plastic Surgery device
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Sep 2018
Decision
98d
Days
Class 2
Risk

K181652 is an FDA 510(k) clearance for the Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable 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 September 28, 2018 after a review of 98 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 K181652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2018
Decision Date September 28, 2018
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
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 K181652.
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
K183183 · Ethicon, Inc. · Jun 2019
WEGO-PGLA RAPID
K183001 · Foosin Medical Supplies Inc., Ltd. · Jan 2019
WEGO-PGA RAPID
K183004 · Foosin Medical Supplies Inc., Ltd. · Jan 2019
Caprolon
K181320 · Resorba Medical GmbH · Sep 2018
Rondek PGA Suture (Beige or Violet)
K180625 · Rk Manufacturing Corporation · May 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K173874 · Origami Surgical, LLC · May 2018