510(k) K142866 ยท GXH Device, Surgical, Cryogenic
Myoscience iovera system
| Applicant | Myoscience, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 21, 2015 |
| Received | Oct 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142866
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.