Cryoprobe CP-2004058
Cryoprobe CP-2004058 is a Class II device made by Icecure Medical Ltd, cleared under FDA 510(k) K240892 on 28 Jun 2024 and listed in FDA GUDID since 6 May 2025 (UDI-DI 07290015487535), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290015487535 | Date6 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240892 | Date28 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 07290015487535
- FDA 510(k) database K240892
Across registries
- FDA 510(k) K240892 decided 28 Jun 2024 Active
- FDA GUDID UDI-DI 07290015487535 listed 6 May 2025 Listed
Timeline
- Cleared FDA 510(k) K240892
- Listed FDA GUDID 07290015487535
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cryoprobe
- Generic name
- Hand-held cryosurgical system handpiece tip
- Model / reference
- CP-2004058
- Primary DI / UDI-DI
- 07290015487535
- 510(k) Number
- FDA product code
- GEH
- GMDN term
- Hand-held cryosurgical system handpiece tip
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Needle Gauge — 10 GaugeStent Length — 140 Millimeter
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