iovera IST2221
by Pacira Pharmaceuticals, INC
iovera IST2221 is a general cryosurgical system (FDA Class II; FDA product code GXH, Device, Surgical, Cryogenic) made by Pacira Pharmaceuticals, INC, cleared under FDA 510(k) K211334 on 10 Sep 2021 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 00816287020248), active as of 22 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 | Number00816287020248 | Date13 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211334 | Date10 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 00816287020248
- FDA 510(k) database K211334
Across registries
- FDA 510(k) K211334 decided 10 Sep 2021 Active
- FDA GUDID UDI-DI 00816287020248 listed 13 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K211334
- Listed FDA GUDID 00816287020248
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iovera
- Generic name
- General cryosurgical system, cryogen gas, electronic
- Model / reference
- IST2221
- Primary DI / UDI-DI
- 00816287020248
- 510(k) Number
- FDA product code
- GXH
- GMDN term
- General cryosurgical system, cryogen gas, electronic
- Device class
- Class II
- Regulation number
- 882.4250
- GUDID distribution status
- In Commercial Distribution
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