ClearanceBrief
510(k) K250891 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Ca

ApplicantConvatec Limited, Flintshire, GB
DecisionUnknown, Jun 6, 2025
ReceivedMar 25, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250891

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.