Cleared Traditional

K926588 - REVISED LABELING FOR POLYPROPYLENE SUTURE

K926588 is the FDA 510(k) clearance for REVISED LABELING FOR POLYPROPYLENE SUTURE by Look, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAW) cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K926588 · Look, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
381d
Days
Class 2
Risk

K926588 is an FDA 510(k) clearance for the REVISED LABELING FOR POLYPROPYLENE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on December 17, 1993 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Look, Inc. devices

Submission Details

510(k) Number K926588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date December 17, 1993
Days to Decision 381 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 115d · This submission: 381d
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 26
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K926588.
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996
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
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437 · Ethicon, Inc. · Jul 1992
DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED
K911905 · Deknatel, Inc. · Jul 1991