AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP— 510(k) K905379

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K905379 for AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP, Substantially Equivalent on 1991-01-17. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 1990-11-30
Decision date: 1991-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, 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.