ClearanceBrief
510(k) K252644 · NEW Suture, Surgical, Absorbable, Polydioxanone

PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

ApplicantM/s. Meril Endo Surgery Private Limited., Vapi, IN
DecisionSubstantially Equivalent, Sep 23, 2025
ReceivedAug 21, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K252644

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.