The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Myosure Hysteroscopic Tissue Removal System.
| Device ID | K142029 |
| 510k Number | K142029 |
| Device Name: | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Sarah Fairfield |
| Correspondent | Sarah Fairfield HOLOGIC, INC. 250 CAMPUS DRIVE 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 | 2014-07-25 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25420045505107 | K142029 | 000 |
| 15420045505117 | K142029 | 000 |
| 15420045505094 | K142029 | 000 |
| 15420045505087 | K142029 | 000 |
| 15420045505070 | K142029 | 000 |
| 15420045504813 | K142029 | 000 |
| 15420045513839 | K142029 | 000 |