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 | K152723 |
| 510k Number | K152723 |
| 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 Eaton |
| Correspondent | Catherine Eaton 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 | 2015-09-22 |
| Decision Date | 2015-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045505124 | K152723 | 000 |
| 25420045504537 | K152723 | 000 |