UTERMOHLEN CRYO PROFESSIONAL— 510(k) K152203

Substantially Equivalent

Koninklijke (Royal) Utermohlen

FDA 510(k) clearance K152203 for UTERMOHLEN CRYO PROFESSIONAL, Substantially Equivalent on 2015-11-06. Applicant: Koninklijke (Royal) Utermohlen.

Clearance details

Applicant: Koninklijke (Royal) Utermohlen
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2015-08-06
Decision date: 2015-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wolvega, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.