ClearanceBrief
510(k) K080946 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX

ApplicantConmed Endoscopic Technologies, Inc., Billerica MA, US
DecisionSubstantially Equivalent, May 20, 2008
ReceivedApr 3, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080946

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.