FEB — Accessories, Cleaning, For Endoscope Class II
FDA product code FEB covers "Accessories, Cleaning, For Endoscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |