510(k) K250945 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 17, 2025 |
| Received | Mar 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Olympus Corporation of the Americas Brand Name: CleverCut
Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0320;
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 Sphincterotome V (Distal Wire guided)
Model/Catalog Number: KD-VC431Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and g Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-431Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0330;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0725;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V411M-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V431M-0720;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V
Model/Catalog Number: KD-V431M-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used with an Olympus endos 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-VC431Q-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-0320;
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-0330;
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-VC433Q-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-VC433Q-0730;
Software Version: N/A
Product Description: These instruments have been designed to be used w Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-411Q-0720
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-411Q-0730
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.