FEB — Accessories, Cleaning, For Endoscope Class II
Classification Details
- Product Code
- FEB
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241168 | wassenburg medical | System 83 Revolve Endoscope Washer/Disinfector | December 19, 2024 |
| K243433 | steris corporation | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | December 2, 2024 |
| K230930 | steris corporation | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | June 30, 2023 |
| K213833 | medivators | SCOPE BUDDY PLUS Endoscope Flushing Aid | January 14, 2022 |
| K201920 | olympus medical systems | Endoscope Reprocessor OER-Elite | September 1, 2020 |
| K173590 | custom ultrasonics | System 83 Plus Washer/Disinfector | March 30, 2020 |
| K190969 | olympus medical systems | ENDOSCOPE REPROCESSOR OER-Elite | July 9, 2019 |
| K181472 | advanced sterilization products (asp) | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | April 23, 2019 |
| K181865 | steris corporation | Acu-sInQ Complete Endoscope Cleaning Aid System | December 14, 2018 |
| K172677 | medivators | Advantage Plus Pass-Thru | December 19, 2017 |
| K162120 | custom ultrasonics | Scope-Assist Flushing Sink | April 28, 2017 |
| K162128 | medivators | Scope Buddy Plus Endoscope Flushing Aid | December 21, 2016 |
| K152189 | advanced sterilization products (asp) | EVOTECH ECR | July 20, 2016 |
| K140977 | advanced sterilization products | EVOTECH ECR | December 22, 2014 |
| K122172 | custom ultrasonics | SYSTEM 83 PLUS | January 25, 2013 |
| K120357 | olympus medical systems | ENDOSCOPE REPROCESSOR OER-MINI | December 20, 2012 |
| K101158 | langford ic systems | LIC INSTRUMENT PROCESSING SYSTEM | May 6, 2011 |
| K103264 | olympus medical systems corporation | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | February 23, 2011 |
| K102996 | medivators reprocessing systems | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR | January 13, 2011 |
| K092387 | minntech | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | April 5, 2010 |