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 Medivators, Inc., Keymed, Inc. and Advanced Sterilization Products.

58
Total
58
Cleared
207d
Avg days
1981
Since
58 devices
25–48 of 58
Cleared Jun 14, 2007
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
K063876
Medivators Reprocessing Systems
General Hospital · 167d
Cleared Jan 12, 2007
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
K061430
Custom Ultrasonics
General Hospital · 234d
Cleared Oct 26, 2006
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K061899
Advanced Sterilization Products
General Hospital · 115d
Cleared Oct 12, 2006
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
K060458
Langford IC Systems, Inc.
General Hospital · 232d
Cleared Mar 15, 2005
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K040883
Advanced Sterilization Products
General Hospital · 344d
Cleared Oct 19, 2001
RIWO SYSTEM TRAYS
K012309
Richard Wolf Medical Instruments Corp.
General Hospital · 88d
Cleared May 09, 2000
PSK ENDOSCOPE CLEANING SYSTEM
K000216
Psk Connectors Pty, Ltd.
General Hospital · 106d
Cleared Nov 24, 1997
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
K973558
Ultracell Medical Technologies, Inc.
General Hospital · 66d
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 Nov 01, 1994
CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT
K944776
Blue Planet Industries, Inc.
General Hospital · 35d
Cleared Sep 20, 1994
AUTO SUTURE* ANTI-FOG DEVICE**
K944249
United States Surgical, A Division of Tyco Healthc
General Hospital · 21d
Cleared May 17, 1994
BLUE PLANET LENS FOG REDUCTION & CLEANING KIT
K941648
Blue Planet Industries, Inc.
General Hospital · 43d
Cleared May 16, 1994
EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT
K941134
H & C Chemical, Inc.
General Hospital · 68d
Cleared Mar 09, 1994
FLUID PUMP, CP #3
K914524
United States Endoscopy Group, Inc.
General Hospital · 881d
Cleared Feb 22, 1994
DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
K914145
Medivators, Inc.
General Hospital · 890d
Cleared Dec 02, 1993
ENDOWASH
K915620
Novar Medical Industries
General Hospital · 738d
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 Dec 15, 1992
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)
K924655
Cox Medical Ent., Inc.
General Hospital · 91d