Clearance Summary
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM received FDA 510(k) clearance under submission number K122459, sponsored by Boston Scientific Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2012-12-13.
- Submission: K122459
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.5980
- Decision date: 2012-12-13
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.