Clearance Summary
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION received FDA 510(k) clearance under submission number K121612, sponsored by American Medical Systems. 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 2012-07-20.
- Submission: K121612
- Applicant / Sponsor: American Medical Systems
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.5980
- Decision date: 2012-07-20
Classification & Regulation
This clearance is catalogued under FDA product code OTP and 21 CFR 884.5980, within the Obstetrics/Gynecology review panel as a Class III device.