510(k) K161835
K161835 is an FDA 510(k) premarket notification submitted by Myoscience, Inc. for the device "iovera system". The FDA issued a decision of Substantially Equivalent on March 24, 2017. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250. Myoscience, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2017
- Date Received
- July 5, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Surgical, Cryogenic
- Device Class
- Class II
- Regulation Number
- 882.4250
- Review Panel
- NE
- Submission Type