iovera STT21180STIM-5
by Pacira Pharmaceuticals, INC
iovera STT21180STIM-5 is a hand-held cryosurgical system handpiece tip (FDA Class II; FDA product code GXH, Device, Surgical, Cryogenic) made by Pacira Pharmaceuticals, INC, cleared under FDA 510(k) K243677 on 26 Dec 2024 and listed in FDA GUDID since 27 Jul 2026 (UDI-DI 00816287020323), 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 | Number00816287020323 | Date27 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243677 | Date26 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 00816287020323
- FDA 510(k) database K243677
Across registries
- FDA 510(k) K243677 decided 26 Dec 2024 Active
- FDA GUDID UDI-DI 00816287020323 listed 27 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K243677
- Listed FDA GUDID 00816287020323
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iovera
- Generic name
- Hand-held cryosurgical system handpiece tip
- Model / reference
- STT21180STIM-5
- Primary DI / UDI-DI
- 00816287020323
- 510(k) Number
- FDA product code
- GXH
- GMDN term
- Hand-held cryosurgical system handpiece tip
- Device class
- Class II
- Regulation number
- 882.4250
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code GXH (Device, Surgical, Cryogenic).
- cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) by ATRICURE, INC.
- CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS by Cryomedical Instruments, Ltd.
- iovera system by Myoscience, Inc.
- iovera° System by Pacira Biosciences, Inc.
- AtriCure cryoICE cryoSPHERE cryoablation probe by ATRICURE, INC.
- CRYO-TOUCH IV by Myoscience, Inc.
- NEUROSTAT, LLOYD by Spembly Medical, Ltd.
- PAINBLOCKER WA5000 by Wallach Surgical Devices, Inc.
- Cryomedics Neurostat by Spembly Medical, Ltd.
- CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE by Cryomedical Instruemts, Ltd.