Cleared Special

HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (K090183) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090183 · Cook Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
242d
Days
Class 2
Risk

K090183 is an FDA 510(k) clearance for the HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on September 25, 2009 after a review of 242 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook Endoscopy devices

Submission Details

510(k) Number K090183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2009
Decision Date September 25, 2009
Days to Decision 242 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 130d · This submission: 242d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 - KNQ Dilator, Esophageal

All 39
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K090183.
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · Boston Scientific Corp · Oct 2012
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · C.R. Bard, Inc. · Jan 2004
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp. · Dec 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · Cordis Corp. · Jan 2000
CRE(TM) BALLOON DILATATION CATHETER
K974788 · Boston Scientific Corp · Mar 1998