Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)

FDA cleared the Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) from Serpex Medical on Sep 2, 2026 under K262420, a traditional 510(k). The device falls under product code GEH, Unit, Cryosurgical, Accessories, regulated at 21 CFR 878.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 16, 2026. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

Serpex Medical has 2 other decisions in the tracker over the last 12 months: K261068 (Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)), K252874 (Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01).