Product Code: KNQ FDA class 2 21 CFR 876.5365

Dilator, Esophageal

Gastroenterology, Urology

An Esophageal Dilator is a medical device used in gastroenterology to dilate narrowed or strictured regions of the esophagus, restoring luminal patency in patients with esophageal strictures, achalasia, or dysphagia caused by benign or post-procedural narrowing. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNQ and it is regulated under 21 CFR 876.5365 in the Gastroenterology and Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KNQ
Device Class: FDA class 2
Regulation Number: 876.5365
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K122924	CRE FIXED WIRE BALLON DILATION CATHETER	Oct 24, 2012	Substantially Equivalent	Boston Scientific Corp
K093236	ETHICON ENDO-SURGERYOPTICAL DILATOR	Nov 10, 2009	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K090183	HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON	Sep 25, 2009	Substantially Equivalent	Cook Endoscopy
K082995	SMART DILATOR	Feb 06, 2009	Substantially Equivalent	Safestitch Medical
K061937	COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON	Dec 01, 2006	Substantially Equivalent	Cook Endoscopy
K061787	MAXFORCE TTS SINGLE-USE BALLOON DILATOR	Sep 21, 2006	Substantially Equivalent	Boston Scientific Corp
K060302	INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED	Apr 11, 2006	Substantially Equivalent	Cordis Europa, N.V.
K043605	INSCOPE 3-STAGE BALLOON DILATOR	Feb 04, 2005	Substantially Equivalent	Cordis Europa, N.V.
K033936	BARD ELIMINATOR PET BALLOON DILATORS	Jan 14, 2004	Substantially Equivalent	C.R. Bard, Inc.
K031147	OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR	Jan 12, 2004	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K023907	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER	Dec 18, 2002	Substantially Equivalent	Cordis Corp.
K002363	MEDOVATIONS ESOPHAGEAL DILATOR	Nov 01, 2000	Substantially Equivalent	Medovations, Inc.
K993720	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER	Jan 18, 2000	Substantially Equivalent	Cordis Corp.
K983373	IMPACT BALLOON DILATION CATHETER	Jun 22, 1999	Substantially Equivalent	B. Braun/Mcgaw
K990935	JACKSON ESOPHAGEAL DILATOR	May 17, 1999	Substantially Equivalent	Pilling Weck Surgical
K974788	CRE(TM) BALLOON DILATATION CATHETER	Mar 20, 1998	Substantially Equivalent	Boston Scientific Corp
K971320	CRE BALLOON DILATATION CATHETER	Oct 09, 1997	Substantially Equivalent	Boston Scientific Corp
K971615	PATTISON ESOPHAGEAL DILATOR	Jul 24, 1997	Substantially Equivalent	Tri-Med Specialties, Inc.
K961438	BALLON DILATATION CATHETER	Jul 31, 1996	Substantially Equivalent	Boston Scientific Corp
K952656	XXL BALLOON DILATATION CATHETER	Jul 19, 1995	Substantially Equivalent	Boston Scientific Corp
K924646	OVER THE GUIDEWIRE DILATATION SYSTEM	Dec 05, 1994	Substantially Equivalent	Medovations, Inc.
K933845	WILSON-COOK BALLOON INFLATION DEVICE	Nov 29, 1994	Substantially Equivalent	Wilson-Cook Medical, Inc.
K934697	MICROVASIVE MAXFORCE	May 16, 1994	Substantially Equivalent	Boston Scientific Corp
K932015	TRI-MED INFLATABLE ESOPHAGEAL DILATOR	Feb 03, 1994	Substantially Equivalent	Tri-Med Specialties, Inc.
K933992	OLYMPUS SCLEROTHERAPY BALLOON	Dec 21, 1993	Substantially Equivalent	Olympus Corp.
K926038	FLEX-TECH BALLOON DILATOR	Oct 25, 1993	Substantially Equivalent	Cape Tech Medical Products
K900924	WILSON-COOK BALLOON DILATION CATHETERS	Dec 21, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K901424	ESOPHAGEAL BALLOON DILATOR	Jun 21, 1990	Substantially Equivalent	Telemed Systems, Inc.
K884715	ACHELASIA BALLOON DIALATOR	Sep 29, 1989	Substantially Equivalent	Primrose Medical, Inc.
K884712	ESOPHAGEAL AND PYLORIC BALLOON DIALATORS	Sep 08, 1989	Substantially Equivalent	Primrose Medical, Inc.
K883526	PORGES STEPPED NEOPLEX DILATOR	Oct 28, 1988	Substantially Equivalent	Porges Corp.
K881478	MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS	Sep 14, 1988	Substantially Equivalent	Keymed (Medical & Industrial Equipment), Ltd.
K862000	KEYMED FLEXIBLE ESOPHAGEAL DILATORS	Aug 12, 1986	Substantially Equivalent	Keymed, Inc.
K853274	AMERICAN DILATATION SYSTEM	Oct 17, 1985	Substantially Equivalent	American Endoscopy, Inc.
K851955	SAVARY-GILLIARD DILATOR	Jul 25, 1985	Substantially Equivalent	Wilson-Cook Medical, Inc.
K841310	GASTROINTESTINAL DILATOR	Jul 31, 1984	Substantially Equivalent	Thomas J. Fogarty, M.D.
K834451	COAXIAL BALLOON GASTROESOPHAGEAL DILA	Feb 04, 1984	Substantially Equivalent	Thomas J. Fogarty, M.D.
K830991	ESOPHAGEAL BOUGIES	Jun 02, 1983	Substantially Equivalent	Medovations, Inc.
K830586	TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR	Mar 24, 1983	Substantially Equivalent	Keymed, Inc.
K812289	CELESTIN DILATOR	Sep 01, 1981	Substantially Equivalent	Inmed Corp.