510(k) K162109 ยท FAD Stent, Ureteral
Kwart Retro-Inject Ureteral Stent
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Jul 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Cook Inc. Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent
Refere Terminated |
FAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.