IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES— 510(k) K905286

Substantially Equivalent

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

FDA 510(k) clearance K905286 for IFSA STERILE NLYLON MONOFIL 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 GAR
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 GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.