# K250945: 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)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 17, 2025 after 203 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910722 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141991: Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP, Olympus Medical Systems Copr. (2015) Summary page 5.

## Recalls of this device
- Jan 7, 2026 · Class II · Z-1284-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1286-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1280-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1272-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1271-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1269-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1283-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1273-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1274-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1276-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1270-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1275-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1277-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1268-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1281-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1285-2026: Devices which did not undergo thermoforming could deform and lose performance.

## Indications for use
The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts. The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The Single Use 3-Lumen Sphincterotome V KD-V411M/V431M Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope and guidewire. The DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q/431Q Series is intended to be used for apillotomy using high-frequency current in combination with an endoscope.

Source page: https://510kreport.com/device/K250945
Methodology: https://510kreport.com/methodology