Cleared Special

K010993 - ALIEN RX MICRO CANNULA, MODEL 4530

K010993 is an FDA 510(k) clearance for ALIEN RX MICRO CANNULA, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code ODD cleared through the Special 510(k) pathway after a 27-day FDA review.

K010993 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
27d
Days
Class 2
Risk

K010993 is an FDA 510(k) clearance for the ALIEN RX MICRO CANNULA, MODEL 4530. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 30, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 - K010993

510(k) Number K010993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2001
Decision Date April 30, 2001
Days to Decision 27 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
104d faster than avg
Panel avg: 131d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

ODD Device Classification - Class 2, Special Controls

Product Code ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
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 - ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

All 17
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K010993.
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
K171989 · Wilson-Cook Medical, Inc. · Mar 2018
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
K070420 · United States Endoscopy Group, Inc. · Mar 2007
DISPOSABLE BENDING CANNULA PR-233Q
K011149 · The Olympus Optical Co. · May 2001
WILSON-COOK STRICTURE MEASURING CATHETER
K973205 · Wilson-Cook Medical, Inc. · Nov 1997
ERCP CANNULA
K963051 · United States Endoscopy Group, Inc. · Mar 1997
ENDOSCOPIC CATHETER
K953967 · Act Medical, Inc. · Jan 1996
K010993 · ALIEN RX MICRO CANNULA, MODEL 4530
Download PDF FDA Summary Boston Scientific Corp