The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Autocap Rx.
| Device ID | K210353 |
| 510k Number | K210353 |
| Device Name: | AutoCap RX |
| Classification | Endoscope Channel Accessory |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Kyra Mcnamara |
| Correspondent | Kyra Mcnamara Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-05-06 |