Cleared Traditional

REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (K926586) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K926586 · Look, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
386d
Days
Class 2
Risk

K926586 is an FDA 510(k) clearance for the REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on December 22, 1993 after a review of 386 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 878.4830 - 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 K926586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date December 22, 1993
Days to Decision 386 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
271d slower than avg
Panel avg: 115d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
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 - GAL Suture, Absorbable, Natural

All 29
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K926586.
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 1999
SURGICAL SUTURE PACKAGE INSERTS
K930416 · United States Surgical, A Division of Tyco Healthc · Apr 1994
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · United States Surgical, A Division of Tyco Healthc · Dec 1990
ENDOSCOPIC HEMOSTATIC LIGATING LOOP
K902731 · United States Surgical, A Division of Tyco Healthc · Sep 1990
ABSORBABLE SURGICAL GUT SUTURE*
K885018 · United States Surgical, A Division of Tyco Healthc · Aug 1989