Cleared Traditional

K061937 - COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

K061937 is the FDA 510(k) clearance for COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON by Cook Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code KNQ) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K061937 · Cook Endoscopy · Gastroenterology & Urology device
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Dec 2006
Decision
144d
Days
Class 2
Risk

K061937 is an FDA 510(k) clearance for the COOK ENDOSCOPY ESOPHAGEAL 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 December 1, 2006 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K061937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date December 01, 2006
Days to Decision 144 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 130d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 16
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K061937.
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · Boston Scientific Corp · Oct 2012
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236 · Ethicon Endo-Surgery, Inc. · Nov 2009
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · C.R. Bard, Inc. · Jan 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · Ethicon Endo-Surgery, Inc. · Jan 2004
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp. · Dec 2002