Cleared Special

K090183 - HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON

K090183 is an FDA 510(k) clearance for HERCULES 3 STAGE WIRE GUIDED DILATION B..., manufactured by Cook Endoscopy. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Special 510(k) pathway after a 242-day FDA review.

K090183 · Cook Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K090183

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 131d · This submission: 242d
Pathway characteristics
Modification to existing cleared device.

KNQ Device Classification - Class 2, Special Controls

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
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236 · Ethicon Endo-Surgery, Inc. · Nov 2009
SMART DILATOR
K082995 · Safestitch Medical · Feb 2009
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K061937 · Cook Endoscopy · Dec 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302 · Cordis Europa, N.V. · Apr 2006
K090183 · HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
Download PDF FDA Summary Cook Endoscopy