Device, Surgical, Cryogenic
Regulation 882.4250
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GXH
| Company | 510(k)s | Recalls |
|---|---|---|
| Myoscience, Inc. | 8 | 2 |
| AtriCure, Inc. | 7 | 0 |
| Pacira Biosciences, Inc. | 2 | 0 |
| Spembly Medical , Ltd. | 2 | 0 |
| Cryomedical Instruemts , Ltd. | 1 | 0 |
| Cryomedical Instruments, Ltd. | 1 | 0 |
| Pacira Pharmaceuticals, Inc. | 1 | 0 |
| Wallach Surgical Devices, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 2025 | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) AtriCure, Inc. | GXH |
| Dec 26, 2024 | K243677 | iovera° System Pacira Biosciences, Inc. | GXH |
| Oct 29, 2024 | K243157 | AtriCure cryoICE BOX (ACM) AtriCure, Inc. | GXH |
| Oct 26, 2023 | K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE M AtriCure, Inc. | GXH |
| May 20, 2022 | K220656 | iovera System Pacira Biosciences, Inc. | GXH |
| Sep 10, 2021 | K211334 | Iovera System Pacira Pharmaceuticals, Inc. | GXH |
| Dec 23, 2020 | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) AtriCure, Inc. | GXH |
| Nov 9, 2018 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc. | GXH |
| Feb 28, 2018 | K173763 | iovera system Myoscience, Inc. | GXH |
| Feb 15, 2018 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc. | GXH |
| Mar 24, 2017 | K161835 | iovera system Myoscience, Inc. | GXH |
| Jan 21, 2015 | K142866 | Myoscience iovera system Myoscience, Inc. | GXH |
| Nov 25, 2014 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe AtriCure, Inc. | GXH |
| Mar 24, 2014 | K133453 | IOVERA Myoscience, Inc. | GXH |
| Jan 10, 2013 | K123516 | CRYO-TOUCH IV Myoscience, Inc. | GXH |
| Jun 22, 2012 | K120415 | CRYO-TOUCH III Myoscience, Inc. | GXH |
| Sep 17, 2010 | K102021 | CRYO-TOUCH II Myoscience, Inc. | GXH |
| Jun 25, 2010 | K100447 | MYOSCIENCE CRYO-TOUCH Myoscience, Inc. | GXH |
| Mar 24, 2005 | K050272 | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS Cryomedical Instruments, Ltd., GB | GXH |
| Jul 10, 2003 | K031482 | CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE Cryomedical Instruemts , Ltd., GB | GXH |
| Apr 30, 1986 | K854334 | PAINBLOCKER WA5000 Wallach Surgical Devices, Inc. | GXH |
| Aug 12, 1983 | K831963 | CRYOMEDICS NEUROSTAT Spembly Medical , Ltd. | GXH |
| Aug 15, 1978 | K781302 | NEUROSTAT, LLOYD Spembly Medical , Ltd. | GXH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.