KNQ · Class II · 21 CFR 876.5365

FDA Product Code KNQ: Dilator, Esophageal

Leading manufacturers include Boston Scientific Corp, Wilson-Cook Medical, Inc. and Medovations, Inc..

40
Total
40
Cleared
153d
Avg days
1981
Since

FDA 510(k) Cleared Dilator, Esophageal Devices (Product Code KNQ)

40 devices
1–24 of 40
Cleared Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
K122924
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Nov 10, 2009
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 26d
Cleared Sep 25, 2009
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183
Cook Endoscopy
Gastroenterology & Urology · 242d
Cleared Feb 06, 2009
SMART DILATOR
K082995
Safestitch Medical
Gastroenterology & Urology · 121d
Cleared Dec 01, 2006
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K061937
Cook Endoscopy
Gastroenterology & Urology · 144d
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Apr 11, 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302
Cordis Europa, N.V.
Gastroenterology & Urology · 64d
Cleared Feb 04, 2005
INSCOPE 3-STAGE BALLOON DILATOR
K043605
Cordis Europa, N.V.
Gastroenterology & Urology · 36d
Cleared Jan 14, 2004
BARD ELIMINATOR PET BALLOON DILATORS
K033936
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared Jan 12, 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 277d
Cleared Dec 18, 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Nov 01, 2000
MEDOVATIONS ESOPHAGEAL DILATOR
K002363
Medovations, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720
Cordis Corp.
Gastroenterology & Urology · 76d
Cleared Jun 22, 1999
IMPACT BALLOON DILATION CATHETER
K983373
B. Braun/Mcgaw
Gastroenterology & Urology · 271d
Cleared May 17, 1999
JACKSON ESOPHAGEAL DILATOR
K990935
Pilling Weck Surgical
Gastroenterology & Urology · 59d
Cleared Mar 20, 1998
CRE(TM) BALLOON DILATATION CATHETER
K974788
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Oct 09, 1997
CRE BALLOON DILATATION CATHETER
K971320
Boston Scientific Corp
Gastroenterology & Urology · 182d
Cleared Jul 24, 1997
PATTISON ESOPHAGEAL DILATOR
K971615
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 31, 1996
BALLON DILATATION CATHETER
K961438
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jul 19, 1995
XXL BALLOON DILATATION CATHETER
K952656
Boston Scientific Corp
Gastroenterology & Urology · 72d
Cleared Dec 05, 1994
OVER THE GUIDEWIRE DILATATION SYSTEM
K924646
Medovations, Inc.
Gastroenterology & Urology · 812d
Cleared Nov 29, 1994
WILSON-COOK BALLOON INFLATION DEVICE
K933845
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 480d
Cleared May 16, 1994
MICROVASIVE MAXFORCE
K934697
Boston Scientific Corp
Gastroenterology & Urology · 228d
Cleared Dec 21, 1993
OLYMPUS SCLEROTHERAPY BALLOON
K933992
Olympus Corp.
Gastroenterology & Urology · 126d

About Product Code KNQ - Regulatory Context