Clearance Summary
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) received FDA 510(k) clearance under submission number K131581, sponsored by Hologic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2013-08-22.
- Submission: K131581
- Applicant / Sponsor: Hologic, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2013-08-22
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.