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 | K162128 |
| 510k Number | K162128 |
| Device Name: | Scope Buddy Plus Endoscope Flushing Aid |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | MEDIVATORS INC. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Kristin Bergeson Padilla |
| Correspondent | Kristin Bergeson Padilla MEDIVATORS INC. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677964092046 | K162128 | 000 |
| 00677964055140 | K162128 | 000 |
| 00677964056246 | K162128 | 000 |
| 00677964056703 | K162128 | 000 |
| 00677964063640 | K162128 | 000 |
| 00677964073755 | K162128 | 000 |
| 00677964082924 | K162128 | 000 |
| 00677964082948 | K162128 | 000 |
| 00677964082955 | K162128 | 000 |
| 00677964082962 | K162128 | 000 |
| 00677964082979 | K162128 | 000 |
| 00677964082986 | K162128 | 000 |
| 00677964082993 | K162128 | 000 |
| 40677964021983 | K162128 | 000 |