AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES— 510(k) K090470

Substantially Equivalent

Covidien

FDA 510(k) clearance K090470 for AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES, Substantially Equivalent on 2009-05-14. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2009-02-23
Decision date: 2009-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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.