510(k) K950166 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
| Applicant | Olympus America, Inc., Lake Success NY, US |
| Decision | Substantially Equivalent, Feb 22, 1995 |
| Received | Jan 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0330
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-401Q-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-401Q-0730
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-1520
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p 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-1530
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p 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-3030
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Brand Name: Disposable Triple Lumen Sphincterotome
Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0320
Product Description: These instruments have been designed to Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Olympus Corporation of the Americas Product Name: Disposable Triple Lumen Sphincterotome
Model/Catalog Number: KD-401Q-0725
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-3020
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p 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-3025
Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for p Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.