510(k) K160098 ยท FCG Biopsy Needle
Single Use Aspiration Needle NA-U401SX
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Mar 22, 2016 |
| Received | Jan 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2023 | Olympus Corporation of the Americas ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree Open, Classified |
FCG | None listed |
| May 19, 2023 | Olympus Corporation of the Americas To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract
Models: NA-U40 Open, Classified |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.