Cleared Traditional

COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (K061937) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Cook Endoscopy devices

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 39
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
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