ClearanceBrief
510(k) K150023 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Vertessa Lite Y-Mesh

ApplicantCaldera Medical, Inc., Agoura Hills CA, US
DecisionSubstantially Equivalent, Apr 6, 2015
ReceivedJan 6, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K150023

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.