The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Mako 7.
| Device ID | K182975 |
| 510k Number | K182975 |
| Device Name: | MAKO 7 |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Ibhina Sherchan |
| Correspondent | Ibhina Sherchan Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-25 |
| Decision Date | 2019-05-21 |