FDX · Class II · 21 CFR 876.1500

FDA Product Code FDX: Endoscopic Cytology Brush

To Collect Cells For Cytological Evaluation.

Leading manufacturers include Wilson-Cook Medical, Inc., United States Endoscopy Group, Inc. and Telemed Systems, Inc..

44
Total
44
Cleared
93d
Avg days
1977
Since
44 devices
25–44 of 44
Cleared Jun 18, 1990
BRONCHIAL CYTOLOGY BRUSH
K901436
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Apr 09, 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Jan 29, 1990
PORGES CYTOLOGY BRUSHES
K896425
Porges Corp.
Gastroenterology & Urology · 82d
Cleared Dec 21, 1989
WILTEK CYTOLOGY BRUSH
K894863
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Aug 28, 1989
HOBBS MEDICAL MICROBIOLOGY BRUSH
K893729
Hobbs Medical, Inc.
Gastroenterology & Urology · 103d
Cleared Mar 02, 1988
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared May 02, 1986
GASTROINTESTINAL CYTOLOGY BRUSH
K860997
Endovations
Gastroenterology & Urology · 45d
Cleared Oct 04, 1985
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530
E-Z-Em, Inc.
Gastroenterology & Urology · 42d
Cleared Jan 08, 1985
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561
C.R. Bard, Inc.
Gastroenterology & Urology · 48d
Cleared Feb 04, 1984
GASTROINTESTINAL SHEATH BRUSH
K834402
Hobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Nov 14, 1983
MUTO BRUSH
K833330
Microvasive
Gastroenterology & Urology · 48d
Cleared Oct 01, 1979
ENDOSCOPIC CYTOLOGY BRUSHES
K791668
Mill-Rose Laboratory
Gastroenterology & Urology · 34d
Cleared Jun 01, 1977
UROLOGICAL BIOPSY BRUSH SET
K770913
Cook, Inc.
Gastroenterology & Urology · 13d