Myoscience, Inc.
Medical device manufacturer in Fremont, CA.
9510(k) clearances
0PMA approvals
2recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173763 | iovera systemGXH · Traditional | 02/28/2018SE |
| K161835 | iovera systemGXH · Traditional | 03/24/2017SE |
| K142866 | Myoscience iovera systemGXH · Traditional | 01/21/2015SE |
| K133453 | IoveraGXH · Traditional | 03/24/2014SE |
| K123516 | Cryo-Touch IVGXH · Traditional | 01/10/2013SE |
| K120415 | Cryo-Touch IIIGXH · Traditional | 06/22/2012SE |
| K102021 | Cryo-Touch IIGXH · Special | 09/17/2010SE |
| K100447 | Myoscience Cryo-TouchGXH · Traditional | 06/25/2010SE |
| K083493 | Myoscience Cryo-TouchGEH · Traditional | 03/20/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2201-2015 Class II | iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count…The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is… | 07/01/2015Terminated |
| Z-1781-2013 Class II | Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical…The outer box label of the product was labeled with a down revision label which did not include the US… | 06/21/2013Terminated |