ClearanceBrief
510(k) K181153 ยท GEH Unit, Cryosurgical, Accessories

ICEfx Cryoablation System

ApplicantGalil Medical, Inc., Arden Hills MN, US
DecisionSubstantially Equivalent, May 15, 2018
ReceivedMay 1, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K181153

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.