510(k) K910586— AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GDT
Advisory panel: General, Plastic Surgery
Date received: 1991-02-11
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Adverse events under product code GDT

product code GDT

Malfunction: 752
Total: 752

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.