510(k) K151051 ยท FAD Stent, Ureteral
Universa Soft Ureteral Stents and Stent Sets
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jan 11, 2016 |
| Received | Apr 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2020 | Cook Inc. Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder Terminated |
FAD | None listed |
| Jan 4, 2019 | Cook Inc. Universa Soft Ureteral Stent, Global Product No. G49887
G49933
G49934
G49937
G49940
G49941
G49942
G49945
G49947
G49948
G49949
G49950
G49951
G49953
G49955
G49956
G49957
G49958
G49959
G49961
G53145
G536 Terminated |
FAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.