Myoscience, Inc.
Redwood City, CA, US
Myoscience, Inc. appears in FDA device records in Redwood City, CA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Myoscience, Inc. between 2009 and 2018. The busiest year on record is 2010, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173763 | iovera system | GXH | Substantially Equivalent | |
| K161835 | iovera system | GXH | Substantially Equivalent | |
| K142866 | Myoscience iovera system | GXH | Substantially Equivalent | |
| K133453 | IOVERA | GXH | Substantially Equivalent | |
| K123516 | CRYO-TOUCH IV | GXH | Substantially Equivalent | |
| K120415 | CRYO-TOUCH III | GXH | Substantially Equivalent | |
| K102021 | CRYO-TOUCH II | GXH | Substantially Equivalent | |
| K100447 | MYOSCIENCE CRYO-TOUCH | GXH | Substantially Equivalent | |
| K083493 | MYOSCIENCE CRYO-TOUCH | GEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2201-2015 | 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 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue | The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05. | Class II | Terminated | |
| Z-1781-2013 | 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 destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue. | The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain