The following data is part of a premarket notification filed by Steris Corporation with the FDA for Bioshield Biopsy Valve Eus - Linear.
| Device ID | K202583 |
| 510k Number | K202583 |
| Device Name: | BioShield Biopsy Valve EUS - Linear |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | Steris Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Jacqueline Oliver |
| Correspondent | Jacqueline Oliver Steris Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2020-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995199255 | K202583 | 000 |
| 10724995199248 | K202583 | 000 |