The following data is part of a premarket notification filed by Hologic, Inc with the FDA for Myosure Xl Tissue Removal Device For Fluent.
| Device ID | K181974 |
| 510k Number | K181974 |
| Device Name: | MyoSure XL Tissue Removal Device For Fluent |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Hologic, Inc 250 Campus Drive Marlborough, MA 01752 |
| Contact | Rachelle D. Fitzgerald |
| Correspondent | Rachelle D. Fitzgerald 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 | 2018-07-24 |
| Decision Date | 2018-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045507654 | K181974 | 000 |