510(k) K123516 ยท GXH Device, Surgical, Cryogenic
CRYO-TOUCH IV
| Applicant | Myoscience, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 10, 2013 |
| Received | Nov 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.