Cleared Traditional

K250351 - Single Use Electrosurgical Knife (KD-612L, KD-612U) (FDA 510(k) Clearance)

Also includes:
Single Use Electrosurgical Knife (KD-620UR) Single Use Electrosurgical Knife (KD-650L, KD-650U)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250351 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
245d
Days
Class 2
Risk

K250351 is an FDA 510(k) clearance for the Single Use Electrosurgical Knife (KD-612L, KD-612U). Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 10, 2025 after a review of 245 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K250351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 130d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Olympus Surgical Technologies of America
Susan Lewandowski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 186
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K250351.
Vanquish Water Vapor Ablation Device
K252388 · Francis Medical, Inc. · Nov 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · Olympus Medical Systems Corporation · Nov 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · Olympus Medical Systems Corp. · Oct 2025
SureTome™ SW Sphincterotome with DomeTip
K251104 · Wilson Cook Medical · Sep 2025
Aqua Medical RF Vapor Ablation System
K251226 · Aqua Medical, Inc. · Aug 2025
Rezum System
K250584 · Boston Scientific Corporation · Jun 2025