510(k) K210310

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit by Nuance Medical, LLC — Product Code GEH

K210310 is an FDA 510(k) premarket notification submitted by Nuance Medical, LLC for the device "CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit". The FDA issued a decision of Substantially Equivalent on October 22, 2021. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Nuance Medical, LLC has at least 5 other 510(k) clearances on record.