ERBECRYO 2 Cryosurgical Unit and Accessories— 510(k) K261806
Substantially EquivalentErbe Elektromedizin GmbH
FDA 510(k) clearance K261806 for ERBECRYO 2 Cryosurgical Unit and Accessories, Substantially Equivalent on 2026-06-09. Applicant: Erbe Elektromedizin GmbH. Device class: 2.
Summary
Erbe Elektromedizin's ERBECRYO 2 Cryosurgical Unit and Accessories is filed under GEH, cryosurgical units and accessories. The record doesn't list the accessories.
Class II, 21 CFR 878.4350. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
Erbe filed from Tuebingen, Germany. The decision came 8 calendar days after FDA received it (June 1 to June 9, 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
- Special
- Location
- Tuebingen, DE
Recent devices under product code GEH
view all- K260520 — Skin Clinic Nitro Clear for Warts and Skin Tags
- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
More clearances from Erbe Elektromedizin GmbH
view allAdverse 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.