Cleared Traditional

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)

K250945 · Olympus Medical Systems Corp. · Gastroenterology & Urology

Oct 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K250945 is an FDA 510(k) clearance for the 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), a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on October 17, 2025, 203 days after receiving the submission on March 28, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number	K250945 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2025
Decision Date	October 17, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.4300