AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR— 510(k) K914190

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K914190 for AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR, Substantially Equivalent on 1992-05-06. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1991-09-18
Decision date: 1992-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.