ClearanceBrief
510(k) K052175 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000

ApplicantUroplasty, Inc., Minneapolis MN, US
DecisionSubstantially Equivalent, Oct 17, 2005
ReceivedAug 10, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K052175

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.