Atlas FDA

Myoscience iovera system

FDA 510(k) clearance K142866 · decided 2015-01-21

Clearance details

K-number
K142866
Device name
Myoscience iovera system
Applicant
Myoscience, Inc.
Decision
Substantially Equivalent
Date received
2014-10-01
Decision date
2015-01-21
Days to decision
112 days
Clearance type
Traditional
Product code
GXH
Device class
2
Regulation number
882.4250
Medical specialty
Neurology
Advisory committee
Neurology
Location
Redwood City, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectivel recall (Z-2201-2015)Myoscience Inc2015-07-22