MaxTack Motorized Fixation Device— 510(k) K231240

Substantially Equivalent

Covidien

FDA 510(k) clearance K231240 for MaxTack Motorized Fixation Device, Substantially Equivalent on 2023-09-08. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2023-04-28
Decision date: 2023-09-08
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.