# K160241: Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 2, 2016 after 30 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (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-1282-2026: Devices which did not undergo thermoforming could deform and lose performance.

## Indications for use
This instrument has been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Source page: https://510kreport.com/device/K160241
Methodology: https://510kreport.com/methodology