The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Orise Proknife.
| Device ID | K200404 |
| 510k Number | K200404 |
| Device Name: | ORISE ProKnife |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Jennifer Edouard |
| Correspondent | Jennifer Edouard Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | KNS |
| Subsequent Product Code | FQH |
| Subsequent Product Code | GEI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-19 |
| Decision Date | 2020-12-03 |