The following data is part of a premarket notification filed by Steris Corporation with the FDA for Bioshield- Ercp Biopsy Valve, Bioshield Irrigator - Extension Tubing, Bioshield Irrigating Adaptor.
| Device ID | K210342 |
| 510k Number | K210342 |
| Device Name: | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor |
| Classification | Endoscope Channel Accessory |
| Applicant | STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin STERIS Corporation 5976 Heisley Rd 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 | 2021-02-05 |
| Decision Date | 2021-09-03 |