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)

FDA cleared 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) from Olympus Medical Systems Corp. on Oct 17, 2025 under K250945, a traditional 510(k). The device falls under product code KNS, Unit, Electrosurgical, Endoscopic (With Or Without Accessories), regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 28, 2025. The decision came 203 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Olympus Medical Systems Corp. has 8 other decisions in the tracker over the last 12 months: K261183 (EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)), K254056 (THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)), K261260 (HD Camera Head OLYMPUS CH-S200-08-LB), K260580 (Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)).