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 STERIS Corporation.
57
Total
57
Cleared
209d
Avg days
1981
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
132d
recently vs 212d historically
FDA 510(k) Cleared Accessories, Cleaning, For Endoscope Devices (Product Code FEB)
57 devices
Cleared
Dec 19, 2024
System 83 Revolve Endoscope Washer/Disinfector
Wassenburg Medical, Inc.
General Hospital
237d
Cleared
Dec 02, 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
STERIS Corporation
General Hospital
27d
Cleared
Jun 30, 2023
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
STERIS Corporation
General Hospital
88d
Cleared
Jan 14, 2022
SCOPE BUDDY PLUS Endoscope Flushing Aid
Medivators, Inc.
General Hospital
36d
Cleared
Sep 01, 2020
Endoscope Reprocessor OER-Elite
Olympus Medical Systems Corp.
General Hospital
53d
Cleared
Mar 30, 2020
System 83 Plus Washer/Disinfector
Custom Ultrasonics, Inc.
General Hospital
860d
Cleared
Jul 09, 2019
ENDOSCOPE REPROCESSOR OER-Elite
Olympus Medical Systems Corp.
General Hospital
88d
Cleared
Apr 23, 2019
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
Advanced Sterilization Products (Asp)
General Hospital
323d
Cleared
Dec 14, 2018
Acu-sInQ Complete Endoscope Cleaning Aid System
STERIS Corporation
General Hospital
155d
Cleared
Dec 19, 2017
Advantage Plus Pass-Thru
Medivators, Inc.
General Hospital
105d
Cleared
Apr 28, 2017
Scope-Assist Flushing Sink
Custom Ultrasonics, Inc.
General Hospital
270d
Cleared
Dec 21, 2016
Scope Buddy Plus Endoscope Flushing Aid
Medivators, Inc.
General Hospital
142d
Cleared
Jul 20, 2016
EVOTECH ECR
Advanced Sterilization Products (Asp)
General Hospital
350d
Cleared
Dec 22, 2014
EVOTECH ECR
Advanced Sterilization Products
General Hospital
250d
Cleared
Jan 25, 2013
SYSTEM 83 PLUS
Custom Ultrasonics
General Hospital
186d
Cleared
Dec 20, 2012
ENDOSCOPE REPROCESSOR OER-MINI
Olympus Medical Systems Corp.
General Hospital
318d
Cleared
Feb 23, 2011
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
Olympus Medical Systems Corporation
General Hospital
111d
Cleared
Apr 05, 2010
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
Minntech Corp.
General Hospital
243d
Cleared
Feb 12, 2010
ENDOSCOPE REPROCESSOR OER-PRO
Olympus Medical Systems Corporation
General Hospital
134d
Cleared
Nov 13, 2008
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
Advanced Sterilization Products
General Hospital
86d
Cleared
Oct 26, 2006
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
Advanced Sterilization Products
General Hospital
115d
Cleared
Mar 15, 2005
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
Advanced Sterilization Products
General Hospital
344d
Cleared
Oct 19, 2001
RIWO SYSTEM TRAYS
Richard Wolf Medical Instruments Corp.
General Hospital
88d
Cleared
Nov 24, 1997
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
Ultracell Medical Technologies, Inc.
General Hospital
66d
About Product Code FEB - Regulatory Context
510(k) Submission Activity
57 total 510(k) submissions under product code FEB since 1981, with 57 receiving FDA clearance (average review time: 209 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - FEB Product Code
Recent submissions under FEB have taken an average of 132 days to reach a decision - down from 212 days historically, suggesting improved FDA processing for this classification.
FEB devices are reviewed by the General Hospital panel. Browse all General Hospital devices →