The following data is part of a premarket notification filed by Medivators Inc with the FDA for Scope Buddy Plus Endoscope Flushing Aid.
| Device ID | K213833 |
| 510k Number | K213833 |
| Device Name: | SCOPE BUDDY PLUS Endoscope Flushing Aid |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | Medivators Inc 14605 28th Ave North Minneapolis, MN 55447 |
| Contact | Mark Arnold |
| Correspondent | Mark Arnold Medivators Inc 14605 28th Ave North Minneapolis, MN 55447 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-01-14 |