External 25L Dewar CSS-2004055
External 25L Dewar CSS-2004055 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 5 May 2025 (UDI-DI 07290015487528), 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 | Number07290015487528 | Date5 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240892 | Date28 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 07290015487528
- FDA 510(k) database K240892
Across registries
- FDA 510(k) K240892 decided 28 Jun 2024 Active
- FDA GUDID UDI-DI 07290015487528 listed 5 May 2025 Listed
Timeline
- Cleared FDA 510(k) K240892
- Listed FDA GUDID 07290015487528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- External 25L Dewar
- Generic name
- General cryosurgical system, cryogen gas, electronic
- Model / reference
- CSS-2004055
- Primary DI / UDI-DI
- 07290015487528
- 510(k) Number
- FDA product code
- GEH
- GMDN term
- General cryosurgical system, cryogen gas, electronic
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Depth — 736 MillimeterHeight — 1184 MillimeterWidth — 480 Millimeter
Similar devices
Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).
- CRYOSHAPE by Etgar Group H.M.Y.A., Ltd.
- CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T by Brymill Corp.
- MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM, MODELS VS2000 by Sanarus Medical, Inc.
- ATRICURE CRYO1 CRYO-ABLATION PROBE by ATRICURE, INC.
- Urethral Warming Catheter Kit by Varian Medical Systems, Inc.
- truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 by STERIS CORPORATION
- VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM by Cryosurgery, Inc.
- cryoICE croablation probe by ATRICURE, INC.
- ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM by ENDOCARE, INC.
- SEEDNET, MODELS FP6T5, FP5T5, FP5T3 by GALIL MEDICAL LTD