Cleared Traditional

K920437 - SYNTHETIC ABSORBABLE SUTURE, UNDYED

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

K920437 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K920437

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.

GAW Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K920437.
REVISED LABELING FOR POLYPROPYLENE SUTURE
K926588 · Look, Inc. · Dec 1993
SURGILENE POLYPROPYLENE SUTURE
K930587 · Davis & Geck, Inc. · Dec 1993
MOPYLEN SUTURE
K931614 · S. Jackson, 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
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K903584 · Look, Inc. · Oct 1990