ERBECRYO 2 Cryosurgical Unit and Accessories
FDA 510(k) K261806 · Erbe Elektromedizin GmbH
510(k) numberK261806
Submission
- Device name
- ERBECRYO 2 Cryosurgical Unit and Accessories
- Applicant
- Erbe Elektromedizin GmbH
Tuebingen, DE - Received
- June 1, 2026
- Decision date
- June 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional | Serpex Medical | 09/02/2026SE |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional | Serpex Medical | 06/30/2026SE |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | Erbe Elektromedizin GmbH | 04/22/2026SE |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional | Medical Brands Laboratories B.V. | 04/02/2026SE |
| K260377 | XSense Cryoablation System with CryoProbesGEH · Special | IceCure Medical , Ltd. | 02/24/2026SE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional | Medinice S.A. | 02/13/2026SE |
| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
| K253000 | CryoFreeze Wart and Skin Tag RemoverGEH · Special | Cryosurgery, Inc. | 10/16/2025SE |
More from Cryosurgery, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | 04/22/2026SE |
| K253915 | MOVIVA® Hybrid Ablation ProbeGEI · Traditional | 12/18/2025SE |
| K251108 | Erbe ESU Model VIO® 3n with AccessoriesGEI · Traditional | 08/29/2025SE |
| K243120 | HybridAPC probeGEI · Traditional | 06/20/2025SE |
| K243451 | FiAPC plus probesGEI · Traditional | 03/21/2025SE |
| K242044 | FiAPC plus probesGEI · Traditional | 08/26/2024SE |
| K240932 | HybridTherm SystemGEI · Traditional | 08/05/2024SE |
| K232033 | HYBRIDknife® flexGEI · Traditional | 11/29/2023SE |
| K231023 | ERBEJET® 2 SystemFQH · Traditional | 06/15/2023SE |
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…GEH · Traditional | 01/07/2020SE |
Questions and answers
When was ERBECRYO 2 Cryosurgical Unit and Accessories cleared by the FDA?
ERBECRYO 2 Cryosurgical Unit and Accessories (K261806) received a 510(k) decision of Substantially Equivalent on June 9, 2026, 8 days after the submission was received.
What is the product code of K261806?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.