AUTO SUTURE SURGICAL MESH DEPLOYER— 510(k) K925148

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K925148 for AUTO SUTURE SURGICAL MESH DEPLOYER, Substantially Equivalent on 1993-02-12. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 1992-10-13
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.