ClearanceBrief
510(k) K242057 ยท GXD Generator, Lesion, Radiofrequency

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

ApplicantAvanos Medical, Inc., Alpharetta GA, US
DecisionSubstantially Equivalent, Aug 14, 2024
ReceivedJul 15, 2024
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K242057

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.