ClearanceBrief
510(k) K253769 ยท FMF Syringe, Piston

Instylla Delivery Kit

ApplicantInstylla, Inc., Bedford MA, US
DecisionSubstantially Equivalent, Dec 22, 2025
ReceivedNov 25, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K253769

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.