Cleared Traditional

Single Use Electrosurgical knife (K171158) - FDA 510(k) Clearance

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

K171158 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Nov 2017
Decision
211d
Days
Class 2
Risk

K171158 is an FDA 510(k) clearance for the Single Use Electrosurgical knife. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 17, 2017 after a review of 211 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 Corp. devices

Submission Details

510(k) Number K171158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date November 17, 2017
Days to Decision 211 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
81d slower than avg
Panel avg: 130d · This submission: 211d
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 Corporation of the Americas
Daphney Germain-Kolawole

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 91
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K171158.
Habib EndoHPB
K180165 · Emcision , Ltd. · Mar 2018
Rezum System
K180237 · Nxthera, Inc. · Feb 2018
Barrx SB RFA Endoscopic Catheter
K173559 · Covidien, LLC · Jan 2018
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241 · Olympus Medical Systems Corp. · Mar 2016
Single Use Balloon Dilator V (with Knife)
K150142 · Olympus Medical Systems Corp. · Oct 2015
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · Boston Scientific Corporation · Apr 2014