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 |