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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2015 | Myoscience Inc iovera 155 Smart Tip;
Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively)
iovera Smart Tips are individually packaged in Tyvek PET pouches, which are
then packaged into 5 or 10 pa Terminated |
GXH | K142866 |
| Jul 20, 2013 | Myoscience Inc Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10.
Product Usage:
The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destro Terminated |
GXH | K123516 |
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