Product code FEB
- Device name
- Accessories, Cleaning, For Endoscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. | 2024-12-19 |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | 2024-12-02 |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023-06-30 |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Medivators, Inc. | 2022-01-14 |
| K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020-09-01 |
| K173590 | System 83 Plus Washer/Disinfector | Custom Ultrasonics, Inc. | 2020-03-30 |
| K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019-07-09 |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Advanced Sterilization Products (Asp) | 2019-04-23 |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | 2018-12-14 |
| K172677 | Advantage Plus Pass-Thru | Medivators, Inc. | 2017-12-19 |
| K162120 | Scope-Assist Flushing Sink | Custom Ultrasonics, Inc. | 2017-04-28 |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | Medivators, Inc. | 2016-12-21 |
| K152189 | EVOTECH ECR | Advanced Sterilization Products (Asp) | 2016-07-20 |
| K140977 | EVOTECH ECR | Advanced Sterilization Products | 2014-12-22 |
| K122172 | SYSTEM 83 PLUS | Custom Ultrasonics | 2013-01-25 |
| K120357 | ENDOSCOPE REPROCESSOR OER-MINI | Olympus Medical Systems Corp. | 2012-12-20 |
| K101158 | LIC INSTRUMENT PROCESSING SYSTEM | Langford IC Systems, Inc. | 2011-05-06 |
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | Olympus Medical Systems Corporation | 2011-02-23 |
| K102996 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR | Medivators Reprocessing Systems | 2011-01-13 |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | Minntech Corp. | 2010-04-05 |
| K093106 | ENDOSCOPE REPROCESSOR OER-PRO | Olympus Medical Systems Corporation | 2010-02-12 |
| K082988 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT | Medivators Reprocessing Systems | 2009-02-13 |
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR | Advanced Sterilization Products | 2008-11-13 |
| K063876 | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING | Medivators Reprocessing Systems | 2007-06-14 |
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | Custom Ultrasonics | 2007-01-12 |
| K061899 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | Advanced Sterilization Products | 2006-10-26 |
| K060458 | MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR | Langford IC Systems, Inc. | 2006-10-12 |
| K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | Advanced Sterilization Products | 2005-03-15 |
| K012309 | RIWO SYSTEM TRAYS | Richard Wolf Medical Instruments Corp. | 2001-10-19 |
| K000216 | PSK ENDOSCOPE CLEANING SYSTEM | Psk Connectors Pty, Ltd. | 2000-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10724995245969 | Rapicide PA High-Level Disinfectant | MEDIVATORS INC. | 2026-03-06 |
| 00724995245962 | Rapicide PA High-Level Disinfectant | MEDIVATORS INC. | 2026-03-06 |
| 00724995355487 | NA | STERIS CORPORATION | 2025-10-21 |
| 00724995355470 | NA | STERIS CORPORATION | 2025-10-21 |
| 00724995244392 | NA | STERIS CORPORATION | 2025-10-21 |
| 40677964055322 | Medivators Hookup | MEDIVATORS INC. | 2025-06-10 |
| 40677964054622 | Medivators Hookup | MEDIVATORS INC. | 2025-04-04 |
| 40677964054448 | Medivators Hookup | MEDIVATORS INC. | 2025-04-04 |
| 00860010835241 | System 83 Revolve | Wassenburg Medical, Inc. | 2025-02-24 |
| 04260306710584 | Sugi | QuestAlpha GmbH & Co. KG | 2024-12-02 |
| 04260306710577 | Sugi | QuestAlpha GmbH & Co. KG | 2024-12-02 |
| 10705037069316 | EVOTECH™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2024-06-20 |
| 00724995225209 | NA | STERIS CORPORATION | 2024-06-03 |
| 00724995225216 | NA | STERIS CORPORATION | 2024-06-03 |
| 00724995225223 | NA | STERIS CORPORATION | 2024-06-03 |
| 00724995225230 | NA | STERIS CORPORATION | 2024-06-03 |
| 00724995225247 | NA | STERIS CORPORATION | 2024-06-03 |
| 00677964093067 | Scope Buddy Plus Blanking Cap | MEDIVATORS INC. | 2022-12-20 |
| 04953170452024 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V | OLYMPUS MEDICAL SYSTEMS CORP. | 2022-06-01 |
| 04953170441271 | SINGLE USE DISTAL COVER | OLYMPUS MEDICAL SYSTEMS CORP. | 2022-06-01 |
| 40677964021976 | Scope Buddy Plus Tubing | MEDIVATORS INC. | 2021-07-02 |
| 00724995201807 | NA | Corporation Steris Canada | 2020-10-16 |
| 04953170405563 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-01-27 |
| 00677964090172 | Rapicide PA High-Level Disinfectant | MEDIVATORS INC. | 2017-04-20 |
| SYSTEM83PLUS9 | SYSTEM 83 PLUS | Wassenburg Medical, Inc. | 2016-09-25 |
| 10705037031016 | EVOTECH™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 10705037031092 | EVOTECH™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 10884521066397 | Auto Suture | Covidien LP | 2016-09-24 |
| 00677964063619 | Rapicide PA High-Level Disinfectant | MEDIVATORS INC. | 2016-09-16 |
| 00724995090722 | S40 | STERIS CORPORATION | 2016-09-08 |