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.
Summary
Serpex Medical's clearance covers two items, the Maverix Cryo Biopsy Probe (MCB1000) and the Maverix Cryo Cartridge (CC1000). The record lists one product code for both: GEH, cryosurgical units and accessories.
Class II, 21 CFR 878.4350. General and Plastic Surgery is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Serpex filed from Santa Clara, California. Review took 90 calendar days (April 1 to June 30, 2026).
Clearance details
- Device name as filed
- Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- Applicant
- Serpex Medical
- Product code
- Product 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- K260520 — Skin Clinic Nitro Clear for Warts and Skin Tags
- 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)
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.