510(k) K091721

CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 by New Medical Technologies GmbH — Product Code GEH

K091721 is an FDA 510(k) premarket notification submitted by New Medical Technologies GmbH for the device "CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23". The FDA issued a decision of Substantially Equivalent on October 2, 2009. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.