FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
K Number: K253230
·
Decision Apr 22, 2026
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
16
Review Days
205
Basic Information
- Device Name
- ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K Number
- K253230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Erbe Elektromedizin GmbH
- Date Received
- September 29, 2025
- Decision Date
- April 22, 2026
- Product Code
- GEH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Erbe Elektromedizin GmbH
| K Number | Device Name | ||
|---|---|---|---|
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| K253915 | MOVIVA® Hybrid Ablation Probe | Dec 18, 2025 | Substantially Equivalent |
| K251108 | Erbe ESU Model VIO® 3n with Accessories | Aug 29, 2025 | Substantially Equivalent |
| K243120 | HybridAPC probe | Jun 20, 2025 | Substantially Equivalent |
| K243451 | FiAPC plus probes | Mar 21, 2025 | Substantially Equivalent |
| K242044 | FiAPC plus probes | Aug 26, 2024 | Substantially Equivalent |
| K240932 | HybridTherm System | Aug 5, 2024 | Substantially Equivalent |
| K232033 | HYBRIDknife® flex | Nov 29, 2023 | Substantially Equivalent |
| K231023 | ERBEJET® 2 System | Jun 15, 2023 | Substantially Equivalent |
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter | Jan 7, 2020 | Substantially Equivalent |