FEB · Class II · 21 CFR 876.1500

FDA Product Code FEB: Accessories, Cleaning, For Endoscope

If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include Keymed, Inc., Advanced Sterilization Products and Olympus Medical Systems Corp..

57
Total
57
Cleared
209d
Avg days
1981
Since
57 devices
25–48 of 57
Cleared Mar 03, 1997
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871
Biosearch Medical Products, Inc.
General Hospital · 88d
Cleared Dec 06, 1996
VIRAPUMP II (MODELS AND MODEL M)
K961607
Viatro, Corp.
General Hospital · 225d
Cleared Nov 27, 1995
MILL-ROSE RIGID SCOPE CLEANING BRUSHES
K954745
Mill-Rose Laboratory
General Hospital · 42d
Cleared Jun 23, 1995
EW-10 AND EW-20
K915402
Olympus Corp.
General Hospital · 1297d
Cleared Sep 20, 1994
AUTO SUTURE* ANTI-FOG DEVICE**
K944249
United States Surgical, A Division of Tyco Healthc
General Hospital · 21d
Cleared Mar 09, 1994
FLUID PUMP, CP #3
K914524
United States Endoscopy Group, Inc.
General Hospital · 881d
Cleared Oct 28, 1993
HOBBS MEDICAL CLEANING BRUSH
K933354
Hobbs Medical, Inc.
General Hospital · 111d
Cleared Oct 05, 1993
CANDELA MINIBRUSH
K932930
Candela Laser Corp.
General Hospital · 112d
Cleared Apr 14, 1993
FLEXIBLE URETERONEPHROSOCOPE
K924135
Applied Medical Resources
General Hospital · 239d
Cleared Mar 29, 1993
OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
K921179
Keymed, Inc.
General Hospital · 385d
Cleared Nov 16, 1992
CLEANING BRUSH
K924103
United States Endoscopy Group, Inc.
General Hospital · 95d
Cleared Jun 11, 1990
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN
K901439
Telemed Systems, Inc.
General Hospital · 77d
Cleared Jan 14, 1983
FIBERSCOPE DISINFECTANT IRRIGATOR
K830026
Keymed, Inc.
General Hospital · 10d
Cleared Jan 29, 1982
KEY MED LEEDS ENDOSCOPE DISINFECTOR
K820152
Keymed, Inc.
General Hospital · 10d
Cleared Apr 08, 1981
KEY-MED FIBRESCOPE DISINFECTION TROLLEY
K810818
Keymed, Inc.
General Hospital · 15d