Cleared Traditional

K151474 - Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

K151474 is an FDA 510(k) clearance for Fujifilm Diathermic Slitter (FlushKnife), manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K151474 · Fujifilm Medical System U.S.A., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
262d
Days
Class 2
Risk

K151474 is an FDA 510(k) clearance for the Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter). Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Wayne, US). The FDA issued a Cleared decision on February 18, 2016 after a review of 262 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 Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K151474

510(k) Number K151474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date February 18, 2016
Days to Decision 262 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
131d slower than avg
Panel avg: 131d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

Product Code KGE Forceps, Biopsy, Electric
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 Peers - KGE Forceps, Biopsy, Electric

All 37
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K151474.
Fujifilm Diathermic Slitter (FlushKnife)
K171096 · Fujifilm Medical Systems U.S.A, Inc. · May 2017
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
K161186 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2016
Disposable Hot Biopsy Forceps
K160625 · Micro-Tech (Nanjing) Co., Ltd. · Jun 2016
ENDO-MARYLAND DISSECTOR
K141794 · Ovesco Endoscopy AG · Nov 2014
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · Endochoice, Inc. · Oct 2013
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010