ClearanceBrief
510(k) K003978 ยท NEY System, Ablation, Microwave And Accessories

AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007

ApplicantAfx, Inc., Fremont CA, US
DecisionSubstantially Equivalent, May 22, 2001
ReceivedDec 22, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K003978

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.