Panels › Gastroenterology, Urology › Product code FEB · Class 2
Accessories, Cleaning, For Endoscope
Regulation 876.1500
1510(k)s in 12 months (58 all time)
20recalls in 12 months (43 all time)
43recalls that name a 510(k)
Top companies in FEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corporation of the Americas | 0 | 21 |
| STERIS Corporation | 4 | 9 |
| Advanced Sterilization Products | 4 | 8 |
| Custom Ultrasonics | 4 | 1 |
| Olympus Medical Systems Corp. | 5 | 0 |
| Keymed, Inc. | 4 | 0 |
| Medivators, Inc. | 4 | 0 |
| Aizu Olympus Co., Ltd. | 0 | 3 |
| Cox Medical Ent., Inc. | 3 | 0 |
| Medivators Reprocessing Systems | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor Steris | FEB |
| Dec 19, 2024 | K241168 | System 83 Revolve Endoscope Washer/Disinfector Wassenburg Medical, Inc. | FEB |
| Dec 2, 2024 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System STERIS Corporation | FEB |
| Jun 30, 2023 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System STERIS Corporation | FEB |
| Jan 14, 2022 | K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid Medivators, Inc. | FEB |
| Sep 1, 2020 | K201920 | Endoscope Reprocessor OER-Elite Olympus Medical Systems Corp., JP | FEB |
| Mar 30, 2020 | K173590 | System 83 Plus Washer/Disinfector Custom Ultrasonics, Inc. | FEB |
| Jul 9, 2019 | K190969 | ENDOSCOPE REPROCESSOR OER-Elite Olympus Medical Systems Corp., JP | FEB |
| Apr 23, 2019 | K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor Advanced Sterilization Products (Asp) | FEB |
| Dec 14, 2018 | K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System STERIS Corporation | FEB |
| Dec 19, 2017 | K172677 | Advantage Plus Pass-Thru Medivators, Inc. | FEB |
| Apr 28, 2017 | K162120 | Scope-Assist Flushing Sink Custom Ultrasonics, Inc. | FEB |
| Dec 21, 2016 | K162128 | Scope Buddy Plus Endoscope Flushing Aid Medivators, Inc. | FEB |
| Jul 20, 2016 | K152189 | EVOTECH ECR Advanced Sterilization Products (Asp) | FEB |
| Dec 22, 2014 | K140977 | EVOTECH ECR Advanced Sterilization Products | FEB |
| Jan 25, 2013 | K122172 | SYSTEM 83 PLUS Custom Ultrasonics | FEB |
| Dec 20, 2012 | K120357 | ENDOSCOPE REPROCESSOR OER-MINI Olympus Medical Systems Corp. | FEB |
| May 6, 2011 | K101158 | LIC INSTRUMENT PROCESSING SYSTEM Langford IC Systems, Inc. | FEB |
| Feb 23, 2011 | K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO Olympus Medical Systems Corporation | FEB |
| Jan 13, 2011 | K102996 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR Medivators Reprocessing Systems | FEB |
| Apr 5, 2010 | K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM Minntech Corp. | FEB |
| Feb 12, 2010 | K093106 | ENDOSCOPE REPROCESSOR OER-PRO Olympus Medical Systems Corporation | FEB |
| Feb 13, 2009 | K082988 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT Medivators Reprocessing Systems | FEB |
| Nov 13, 2008 | K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR Advanced Sterilization Products | FEB |
| Jun 14, 2007 | K063876 | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING Medivators Reprocessing Systems | FEB |
| Jan 12, 2007 | K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR Custom Ultrasonics | FEB |
| Oct 26, 2006 | K061899 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products | FEB |
| Oct 12, 2006 | K060458 | MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR Langford IC Systems, Inc. | FEB |
| Mar 15, 2005 | K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products | FEB |
| Oct 19, 2001 | K012309 | RIWO SYSTEM TRAYS Richard Wolf Medical Instruments Corp. | FEB |
| May 9, 2000 | K000216 | PSK ENDOSCOPE CLEANING SYSTEM Psk Connectors Pty, Ltd. | FEB |
| Nov 24, 1997 | K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) Ultracell Medical Technologies, Inc. | FEB |
| Mar 3, 1997 | K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS Biosearch Medical Products, Inc. | FEB |
| Dec 6, 1996 | K961607 | VIRAPUMP II (MODELS AND MODEL M) Viatro, Corp. | FEB |
| Nov 27, 1995 | K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES Mill-Rose Laboratory | FEB |
| Jun 23, 1995 | K915402 | EW-10 AND EW-20 Olympus Corp. | FEB |
| Nov 1, 1994 | K944776 | CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT Blue Planet Industries, Inc. | FEB |
| Sep 20, 1994 | K944249 | AUTO SUTURE* ANTI-FOG DEVICE** United States Surgical, A Division of Tyco Healthc | FEB |
| May 17, 1994 | K941648 | BLUE PLANET LENS FOG REDUCTION & CLEANING KIT Blue Planet Industries, Inc. | FEB |
| May 16, 1994 | K941134 | EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT H & C Chemical, Inc. | FEB |
| Mar 9, 1994 | K914524 | FLUID PUMP, CP #3 United States Endoscopy Group, Inc. | FEB |
| Feb 22, 1994 | K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES Medivators, Inc. | FEB |
| Dec 2, 1993 | K915620 | ENDOWASH Novar Medical Industries | FEB |
| Oct 28, 1993 | K933354 | HOBBS MEDICAL CLEANING BRUSH Hobbs Medical, Inc. | FEB |
| Oct 5, 1993 | K932930 | CANDELA MINIBRUSH Candela Laser Corp. | FEB |
| Apr 14, 1993 | K924135 | FLEXIBLE URETERONEPHROSOCOPE Applied Medical Resources | FEB |
| Mar 29, 1993 | K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 Keymed, Inc., GB | FEB |
| Dec 15, 1992 | K924655 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) Cox Medical Ent., Inc. | FEB |
| Nov 16, 1992 | K924103 | CLEANING BRUSH United States Endoscopy Group, Inc. | FEB |
| Sep 23, 1992 | K923687 | ONE DIRECTIONAL CLEANING BRUSH Endoscopy Support Services, Inc. | FEB |
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