Cleared Traditional

K926167 - POLYVIOLENE SUTURE-REVISED LABELING

K926167 is the FDA 510(k) clearance for POLYVIOLENE SUTURE-REVISED LABELING by Look, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K926167 · Look, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
381d
Days
Class 2
Risk

K926167 is an FDA 510(k) clearance for the POLYVIOLENE SUTURE-REVISED LABELING. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 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 878.5000 - 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 K926167 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 GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K926167.
ENDOBUTTON CONTINUOUS LOOP
K980155 · Smith & Nephew, Inc. · Apr 1998
USSC NONABSORBABLE SUTURES
K955747 · United States Surgical, A Division of Tyco Healthc · Feb 1996
ACUFEX ENDOBUTTON TAPE
K952535 · Acufex Microsurgical, Inc. · Feb 1996
SILK SUTURES
K930590 · Davis & Geck, Inc. · Dec 1993
TI-CRON AND DACRON SUTURES
K930591 · Davis & Geck, Inc. · Dec 1993
MEDSURG MARSHMALLOW TRAY
K920421 · Medsurg Industries, Inc. · Dec 1993