ClearanceBrief
510(k) K122459 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM

ApplicantBoston Scientific Corporation, Marlboro MA, US
DecisionSubstantially Equivalent, Dec 13, 2012
ReceivedAug 13, 2012
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K122459

DateFirm and productCodeLinked 510(k)
May 4, 2018Boston Scientific Corporation
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Terminated		 PWINone listed
May 4, 2018Boston Scientific Corporation
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Terminated		 PWINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.