AUTOSUTURE ENDOSCOPIC SUTURING DEVICE— 510(k) K934738

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K934738 for AUTOSUTURE ENDOSCOPIC SUTURING DEVICE, Substantially Equivalent on 1994-03-16. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 1993-10-01
Decision date: 1994-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.