ClearanceBrief
510(k) K250977 ยท NEW Suture, Surgical, Absorbable, Polydioxanone

Suture-TOOL System

ApplicantSuturion AB, Lund, SE
DecisionSubstantially Equivalent, Apr 28, 2025
ReceivedMar 31, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250977

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.