Company ยท US
Myoscience, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2018. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2018 | K173763 | iovera system Myoscience, Inc. | GXH |
| Mar 24, 2017 | K161835 | iovera system Myoscience, Inc. | GXH |
| Jan 21, 2015 | K142866 | Myoscience iovera system Myoscience, 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 20, 2009 | K083493 | MYOSCIENCE CRYO-TOUCH Myoscience, Inc. | GEH |
Latest recalls
| 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 |