IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES— 510(k) K905287

Substantially Equivalent

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

FDA 510(k) clearance K905287 for IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES, Substantially Equivalent on 1991-02-11. Applicant: Internacional Farmaceutica, S.A. DE C.V..

Clearance details

Applicant: Internacional Farmaceutica, S.A. DE C.V.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 1990-11-26
Decision date: 1991-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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.