Cleared Special

K102082 - EXTRACTOR PRO RX RETRIEVAL BALLONS

K102082 is the FDA 510(k) clearance for EXTRACTOR PRO RX RETRIEVAL BALLONS by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 28-day FDA review.

K102082 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 2010
Decision
28d
Days
Class 2
Risk

K102082 is an FDA 510(k) clearance for the EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRA.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on August 23, 2010 after a review of 28 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.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K102082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2010
Decision Date August 23, 2010
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 263
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K102082.
CHARGER BALLOON DILATATION CATHETER
K112701 · Boston Scientific · Oct 2011
MUSTANG BALLOON DILATAION CATHETERS
K110122 · Boston Scientific · May 2011
SINGLE USE BILIARY DRAINAGE STENT V
K103478 · Olympus Medical Systems Corporation · Feb 2011
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · Boston Scientific Corp · Jul 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp · Jul 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
K101095 · Wilson-Cook Medical, Inc. · Jul 2010