Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)— 510(k) K261068
Substantially EquivalentSerpex Medical
FDA 510(k) clearance K261068 for Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000), Substantially Equivalent on 2026-06-30. Applicant: Serpex Medical. Device class: 2.
Clearance details
- Device name as filed
- Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- Applicant
- Serpex Medical
- Product code
- Code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code GEH
view all- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
- K260377 — XSense Cryoablation System with CryoProbes
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.