510(k) K261068

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) by Serpex Medical — Product Code GEH

K261068 is an FDA 510(k) premarket notification submitted by Serpex Medical for the device "Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)". The FDA issued a decision of Substantially Equivalent on June 30, 2026. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Serpex Medical has at least 3 other 510(k) clearances on record.