The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Myosure Manual Tissue Removal Device.
| Device ID | K173901 |
| 510k Number | K173901 |
| Device Name: | MyoSure MANUAL Tissue Removal Device |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Hologic, Inc. 250 Campus Drive Marlbrough, MA 01752 |
| Contact | Anne-marie Keefe |
| Correspondent | Anne-marie Keefe Hologic, Inc. 250 Campus Drive Marlbrough, 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 | 2017-12-22 |
| Decision Date | 2018-05-08 |
| Summary: | summary |