Cleared Special

K093236 - ETHICON ENDO-SURGERYOPTICAL DILATOR

K093236 is an FDA 510(k) clearance for ETHICON ENDO-SURGERYOPTICAL DILATOR, manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Special 510(k) pathway after a 26-day FDA review.

K093236 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
26d
Days
Class 2
Risk

K093236 is an FDA 510(k) clearance for the ETHICON ENDO-SURGERYOPTICAL DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 10, 2009 after a review of 26 days - a notably fast clearance 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. 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 - K093236

510(k) Number K093236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2009
Decision Date November 10, 2009
Days to Decision 26 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
105d faster than avg
Panel avg: 131d · This submission: 26d
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 34
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K093236.
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · Boston Scientific Corp · Oct 2012
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183 · Cook Endoscopy · Sep 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
K093236 · ETHICON ENDO-SURGERYOPTICAL DILATOR
Download PDF FDA Summary Ethicon Endo-Surgery,…