Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351): 510(k) cleared Oct 10, 2025

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

Olympus Medical Systems Corporation · Oct 10, 2025 · K250351

FDA cleared the Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) from Olympus Medical Systems Corporation on Oct 10, 2025 under K250351, 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 Feb 7, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Olympus Medical Systems Corporation 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)).

Questions & Answers

What did FDA clear under K250351?

K250351 is the FDA 510(k) for Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U), submitted by Olympus Medical Systems Corporation. FDA's decision date was Oct 10, 2025, under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)).

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

Olympus Medical Systems Corporation, based in Hachioji-Shi, is the applicant of record for K250351.

How long did the K250351 review take?

FDA received the submission on Feb 7, 2025 and issued its decision on Oct 10, 2025, 245 days later.

← All decisions in October 2025