The following data is part of a premarket notification filed by Steris Corporation with the FDA for Bioguard Eus Air/water And Suction Valves.
| Device ID | K202104 |
| 510k Number | K202104 |
| Device Name: | BioGuard EUS Air/Water And Suction Valves |
| Classification | Endoscope Channel Accessory |
| Applicant | Steris Corporation 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin Steris Corporation 5976 Heisley Road Mentor, OH 44060 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-29 |
| Decision Date | 2021-01-14 |