Cleared Traditional

K151474 - Fujifilm Diathermic Slitter (FlushKnife)

K151474 is the FDA 510(k) clearance for Fujifilm Diathermic Slitter (FlushKnife) by Fujifilm Medical System U.S.A., Inc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
132d slower than avg
Panel avg: 130d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
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
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000