510(k) K193517 ยท KTI Bronchoscope Accessory
ViziShot 2 FLEX
| Applicant | Olympus Surgical Technologies America, Southborough MA, US |
| Decision | Substantially Equivalent, Mar 18, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | Olympus Corporation of the Americas ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019.
The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The she Open, Classified |
KTI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.