ClearanceBrief
510(k) K214070 ยท FTM Mesh, Surgical

OviTex PRS (Long Term Resorbable)

ApplicantTela Bio, Malvern PA, US
DecisionSubstantially Equivalent, Mar 21, 2023
ReceivedDec 27, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K214070

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.