K240776
- 510(k) number
- K240776
- Device name
- Celsio Flexible Cryocatheter System
- Applicant
- Endocision Technologies, Inc. CA
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2024-09-24
- Date received
- 2024-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240776.pdf
Official FDA record: K240776
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.