510(k) K171602 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Williams Cystoscopic Injection Needle
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 28, 2017 |
| Received | Jun 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Cook Incorporated Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112 Open, Classified |
FBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.