Clearance Summary
PELVIC FLOOR REPAIR SYSTEM received FDA 510(k) clearance under submission number K091131, sponsored by Boston Scientific. 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 2009-05-08.
- Submission: K091131
- Applicant / Sponsor: Boston Scientific
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.5980
- Decision date: 2009-05-08
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.