ERBECRYO 2 Cryosurgical Unit and Accessories— 510(k) K261806

Substantially Equivalent

Erbe Elektromedizin GmbH

FDA 510(k) clearance K261806 for ERBECRYO 2 Cryosurgical Unit and Accessories, Substantially Equivalent on 2026-06-09. Applicant: Erbe Elektromedizin GmbH.

Clearance details

Applicant: Erbe Elektromedizin GmbH
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2026-06-01
Decision date: 2026-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Tuebingen, DE

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.