510(k) K160241 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Mar 2, 2016 |
| Received | Feb 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC412Q-0215;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.