Cleared Special

K112701 - CHARGER BALLOON DILATATION CATHETER

K112701 is an FDA 510(k) clearance for CHARGER BALLOON DILATATION CATHETER, manufactured by Boston Scientific. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 39-day FDA review.

K112701 · Boston Scientific · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
39d
Days
Class 2
Risk

K112701 is an FDA 510(k) clearance for the CHARGER BALLOON DILATATION CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on October 25, 2011 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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.

FDA 510(k) Submission Details - K112701

510(k) Number K112701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2011
Decision Date October 25, 2011
Days to Decision 39 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
92d faster than avg
Panel avg: 131d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 476
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K112701.
HANAROSTENT BILIARY (NNN)
K111149 · M.I. Tech Co., Ltd. · Dec 2011
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K112522 · Flexible Stenting Solutions, Inc. · Dec 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
K112543 · Boston Scientific Corporation · Dec 2011
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
K111766 · Idev Technologies, Inc. · Oct 2011
MULTIPURPOSE DRAINAGE CATHETER
K111315 · Navilyst Medical, Inc. · Jun 2011
MUSTANG BALLOON DILATAION CATHETERS
K110122 · Boston Scientific · May 2011
K112701 · CHARGER BALLOON DILATATION CATHETER
Download PDF FDA Summary Boston Scientific