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)

by Olympus Medical Systems Corp.

510(k) K250945

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K250945↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK250945	Date17 Oct 2025Cleared	StatusActive

Recalls

16 recalls · 16 ongoing · FDA

16 recalls, same reason
- Ongoing Z-1285-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1274-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1280-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1272-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1276-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1284-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1271-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1270-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1268-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1281-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1275-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1277-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1269-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1273-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1286-2026 FDA Class II initiated 7 Jan 2026
- Ongoing Z-1283-2026 FDA Class II initiated 7 Jan 2026
Devices which did not undergo thermoforming could deform and lose performance.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K250945
FDA Product Code: KNS
Models / Variants: 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)

Device Class: Class II
Regulation: 21 CFR Part 876.4300
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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