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
40 devices
25–40 of 40
Cleared Dec 21, 1990
WILSON-COOK BALLOON DILATION CATHETERS
K900924
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 297d
Cleared Jun 21, 1990
ESOPHAGEAL BALLOON DILATOR
K901424
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 28, 1988
PORGES STEPPED NEOPLEX DILATOR
K883526
Porges Corp.
Gastroenterology & Urology · 71d
Cleared Aug 12, 1986
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000
Keymed, Inc.
Gastroenterology & Urology · 81d
Cleared Oct 17, 1985
AMERICAN DILATATION SYSTEM
K853274
American Endoscopy, Inc.
Gastroenterology & Urology · 73d
Cleared Jul 25, 1985
SAVARY-GILLIARD DILATOR
K851955
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 02, 1983
ESOPHAGEAL BOUGIES
K830991
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 24, 1983
TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR
K830586
Keymed, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 01, 1981
CELESTIN DILATOR
K812289
Inmed Corp.
Gastroenterology & Urology · 19d