510(k) K161236 ยท FAD Stent, Ureteral
Universa Firm Ureteral Stents and Stent Sets
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jan 27, 2017 |
| Received | May 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161236
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.