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 one other decision in the tracker over the last 12 months: K261068 (Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)).
Questions & Answers
What did FDA clear under K262420?
K262420 is the FDA 510(k) for Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000), submitted by Serpex Medical. FDA's decision date was Sep 2, 2026, under product code GEH (Unit, Cryosurgical, Accessories).
Who makes the Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)?
Serpex Medical, based in Santa Clara, CA, is the applicant of record for K262420. The company is listed in the MedDevice Startups directory.
How long did the K262420 review take?
FDA received the submission on Jul 16, 2026 and issued its decision on Sep 2, 2026, 48 days later.