ClearanceBrief
510(k) K251247 ยท GXD Generator, Lesion, Radiofrequency

GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency G

ApplicantBoston Scientific Neuromodulation Corporation, Valencia CA, US
DecisionSubstantially Equivalent, Aug 7, 2025
ReceivedApr 23, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251247

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.