Cleared Special

K110887 - INJECTION GOLD PROBE BIPOLAR ELECTROHEM...

K110887 is the FDA 510(k) clearance for INJECTION GOLD PROBE BIPOLAR ELECTROHEM... by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Special 510(k) pathway after a 15-day FDA review.

K110887 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
15d
Days
Class 2
Risk

K110887 is an FDA 510(k) clearance for the INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on April 14, 2011 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K110887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date April 14, 2011
Days to Decision 15 days
Submission Type Special
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 faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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

All 115
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K110887.
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
K130623 · Covidien, LLC · Jul 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
K122505 · Olympus Medical Systems Corp. · Apr 2013
TRUETOME
K122203 · Boston Scientific Corp · Aug 2012
GYRUS ACMI BIOCOAG PROBE
K092571 · Gyrus Acmi, Inc. · Oct 2010
MERIT BIPOLAR COAGULATION PROBE
K102273 · Merit Medical Systems, Inc. · Sep 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
K101139 · Medtronic, Inc. · May 2010