510(k) K141991 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP
| Applicant | Olympus Medical Systems Copr., Center Valley PA, US |
| Decision | Substantially Equivalent, Mar 31, 2015 |
| Received | Jul 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141991
| 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-VC411Q-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC411Q-0725;
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.