ATS 5000 Automatic Tourniquet Instrument— 510(k) K202919

Substantially Equivalent

Mcewen and Associates Consulting , Ltd.

FDA 510(k) clearance K202919 for ATS 5000 Automatic Tourniquet Instrument, Substantially Equivalent on 2021-05-20. Applicant: Mcewen and Associates Consulting , Ltd..

Clearance details

Applicant: Mcewen and Associates Consulting , Ltd.
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 2020-09-29
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.