510(k) K903780— AUTO SUTURE LAPAROSCOPY ACCESSORY KIT

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1990-08-20
Decision date: 1990-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.