ClearanceBrief
510(k) K253527 · GAG Stapler, Surgical

Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)

ApplicantCovidien, LLC, North Haven CT, US
DecisionSubstantially Equivalent, Jul 1, 2026
ReceivedNov 13, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253527

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.