DeviceClearance

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe— 510(k) K253230

Substantially Equivalent

Erbe Elektromedizin GmbH

FDA 510(k) clearance K253230 for ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe, Substantially Equivalent on 2026-04-22. Applicant: Erbe Elektromedizin GmbH. Device class: 2.

Summary

Erbe Elektromedizin's record is titled ERBECRYO 2 Cryosurgical Unit and Accessories and names two parts: the ERBECRYO 2 cryosurgical unit and the Erbe Flexible Cryoprobe. Both are filed under product code GEH (Unit, Cryosurgical, Accessories).

Class II, 21 CFR 878.4350. It came in as a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.

Erbe Elektromedizin filed from Tuebingen, Germany. Review took 205 calendar days (September 29, 2025 to April 22, 2026).

Clearance details

Applicant
Erbe Elektromedizin GmbH
Product code
Product code GEH
Device class
Class 2
Regulation
21 CFR 878.4350
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuebingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEH

product code GEH
Death
25
Injury
351
Malfunction
901
Total
1,277

Source: openFDA MAUDE database, through . 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.