STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES— 510(k) K911354

Substantially Equivalent

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

FDA 510(k) clearance K911354 for STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES, Substantially Equivalent on 1991-10-25. Applicant: Internacional Farmaceutica, S.A. DE C.V..

Clearance details

Applicant: Internacional Farmaceutica, S.A. DE C.V.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 1991-03-26
Decision date: 1991-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.