About This 510(k) Submission
K252889 is an FDA 510(k) clearance for the Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M), a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Olympus Medical Systems Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 25, 2025, 76 days after receiving the submission on September 10, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.