K261068
- 510(k) number
- K261068
- Device name
- Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- Applicant
- Serpex Medical CA · US
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2026-06-30
- Date received
- 2026-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K261068.pdf
Official FDA record: K261068
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.