The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Myosure Xl Tissue Removal Device (1 Pack) Myosure Xl Tissue Removal Device (3 Pack).
| Device ID | K122498 |
| 510k Number | K122498 |
| Device Name: | MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2012-09-10 |
| Summary: | summary |