510(k) K190829 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
| Applicant | Wilson-Cook Medical Inc./Cook Endoscopy, Winston-Salem NC, US |
| Decision | Substantially Equivalent, Dec 19, 2019 |
| Received | Apr 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190829
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.