ClearanceBrief
510(k) K182709 ยท KOB Catheter, Suprapubic (And Accessories)

One-Step Suprapubic Introducer

ApplicantCook Incorporated, Bloomington IN, US
DecisionSubstantially Equivalent, Dec 26, 2018
ReceivedSep 27, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K182709

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.