Cleared Abbreviated

K101657 - RADIAL 4 HOT BIOPSY FORCEPS BOX 5

Also marketed or referenced as:
RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20 RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40

K101657 is an FDA 510(k) clearance for RADIAL 4 HOT BIOPSY FORCEPS BOX 5, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Abbreviated 510(k) pathway after a 116-day FDA review.

K101657 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
116d
Days
Class 2
Risk

K101657 is an FDA 510(k) clearance for the RADIAL 4 HOT BIOPSY FORCEPS BOX 5. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on October 5, 2010 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K101657

510(k) Number K101657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2010
Decision Date October 05, 2010
Days to Decision 116 days
Submission Type Abbreviated
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
15d faster than avg
Panel avg: 131d · This submission: 116d
Pathway characteristics
Standards-based clearance path.

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 45
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K101657.
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · Fujifilm Medical System U.S.A., Inc. · Feb 2016
ENDO-MARYLAND DISSECTOR
K141794 · Ovesco Endoscopy AG · Nov 2014
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · Endochoice, Inc. · Oct 2013
MULTI-BITE HOT BIOPSY FORCEPS
K090796 · Endo-Therapeutics, Inc. · Nov 2009
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K090583 · Apollo Endosurgery, Inc. · Jun 2009
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
K101657 · RADIAL 4 HOT BIOPSY FORCEPS BOX 5
Download PDF FDA Summary Boston Scientific Corp