Cleared Traditional

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

K250351 · Olympus Medical Systems Corporation · Gastroenterology & Urology

Oct 2025

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K250351 is an FDA 510(k) clearance for the Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U), a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 10, 2025, 245 days after receiving the submission on February 7, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number	K250351 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2025
Decision Date	October 10, 2025
Days to Decision	245 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