510(k) K220656
K220656 is an FDA 510(k) premarket notification submitted by Pacira Biosciences, Inc. for the device "iovera System". The FDA issued a decision of Substantially Equivalent on May 20, 2022. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250. Pacira Biosciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2022
- Date Received
- March 7, 2022
- Clearance Type
- Special
- 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