The following data is part of a premarket notification filed by Steris Corporations with the FDA for Bioguard Air/water And Suction Valves.
| Device ID | K203630 |
| 510k Number | K203630 |
| Device Name: | BioGuard Air/Water And Suction Valves |
| Classification | Endoscope Channel Accessory |
| Applicant | STERIS Corporations 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin STERIS Corporations 5976 Heisley Road Mentor, OH 44060 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-01-08 |