The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Seal Single Use Biopsy Valve.
| Device ID | K182275 |
| 510k Number | K182275 |
| Device Name: | Seal Single Use Biopsy Valve |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Andrew Akers |
| Correspondent | Andrew Akers Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-22 |
| Decision Date | 2018-09-13 |
| Summary: | summary |