AUTO SUTURE POLY GIA SURGICAL STAPLER— 510(k) K843603

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K843603 for AUTO SUTURE POLY GIA SURGICAL STAPLER, Substantially Equivalent on 1984-10-31. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1984-08-20
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.