Cleared Traditional

K920437 - SYNTHETIC ABSORBABLE SUTURE

K920437 is the FDA 510(k) clearance for SYNTHETIC ABSORBABLE SUTURE by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAW) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K920437 · Ethicon, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
178d
Days
Class 2
Risk

K920437 is an FDA 510(k) clearance for the SYNTHETIC ABSORBABLE SUTURE, UNDYED. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 178 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 K920437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1992
Decision Date July 30, 1992
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 25
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K920437.
USSC POLYPROPLENE SUTURE
K954808 · United States Surgical, A Division of Tyco Healthc · Feb 1996
SURGILENE(R) SUTURES
K945701 · Davis & Geck, Inc. · Jan 1995
SURGILENE POLYPROPYLENE SUTURE
K930587 · Davis & Geck, Inc. · Dec 1993
DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED
K911905 · Deknatel, Inc. · Jul 1991
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
K903643 · Deknatel, Inc. · Dec 1990
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872 · United States Surgical, A Division of Tyco Healthc · Sep 1990