Cleared Traditional

K931919 - CATGUT SUTURE CHROMIC

K931919 is an FDA 510(k) clearance for CATGUT SUTURE CHROMIC, manufactured by Surgimetrics International, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K931919 · Surgimetrics International, Ltd. · General & Plastic Surgery device
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Mar 1994
Decision
321d
Days
Class 2
Risk

K931919 is an FDA 510(k) clearance for the CATGUT SUTURE CHROMIC. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Surgimetrics International, Ltd. (Norcross, US). The FDA issued a Cleared decision on March 3, 1994 after a review of 321 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 Surgimetrics International, Ltd. devices

FDA 510(k) Submission Details - K931919

510(k) Number K931919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date March 03, 1994
Days to Decision 321 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
206d slower than avg
Panel avg: 115d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAL Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K931919.
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
K961931 · R. K. Medical L. L. C. · Jul 1996
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
K930738 · Deknatel, Inc. · Jul 1994
SURGICAL SUTURE PACKAGE INSERTS
K930416 · United States Surgical, A Division of Tyco Healthc · Apr 1994
REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES
K926586 · Look, Inc. · Dec 1993
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
K930589 · Davis & Geck, Inc. · Dec 1993
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · United States Surgical, A Division of Tyco Healthc · Dec 1990