Cleared Traditional

STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES (K911354) - FDA 510(k) Clearance

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

K911354 · Internacional Farmaceutica, S.A. DE C.V. · General & Plastic Surgery device
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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

Submission Details

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.

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.