The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Myosure Hysteroscopic Tissue Removal System And Myosure Tissue Removal Devices.
| Device ID | K172566 |
| 510k Number | K172566 |
| Device Name: | Myosure Hysteroscopic Tissue Removal System And Myosure Tissue Removal Devices |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 |
| Contact | Catherine Sanford |
| Correspondent | Catherine Sanford Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-25 |
| Decision Date | 2017-09-20 |
| Summary: | summary |