K243677
- 510(k) number
- K243677
- Device name
- iovera° System
- Applicant
- Pacira Biosciences, Inc. CA · US
- Product code
- GXH — Device, Surgical, Cryogenic
- Decision date
- 2024-12-26
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K243677.pdf
Official FDA record: K243677
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.