K240457
- 510(k) number
- K240457
- Device name
- C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2024-07-24
- Date received
- 2024-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K240457.pdf
Official FDA record: K240457
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.