Cleared Traditional

K911354 - STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES

K911354 is an FDA 510(k) clearance for STERILE PLAIN GUT/CHROMIC GUT ABSORB SU..., manufactured by Internacional Farmaceutica, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K911354 · Internacional Farmaceutica, S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
213d
Days
Class 2
Risk

K911354 is an FDA 510(k) clearance for the STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Internacional Farmaceutica, S.A. DE C.V. (Great Neck, US). The FDA issued a Cleared decision on October 25, 1991 after a review of 213 days - an extended review cycle.

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. 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 Internacional Farmaceutica, S.A. DE C.V. devices

FDA 510(k) Submission Details - K911354

510(k) Number K911354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date October 25, 1991
Days to Decision 213 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 115d · This submission: 213d
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 14
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K911354.
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
PLAIN AND CHROMIC GUT SUTURE
K903624 · Look, Inc. · Sep 1990
ENDOSCOPIC HEMOSTATIC LIGATING LOOP
K902731 · United States Surgical, A Division of Tyco Healthc · Sep 1990