Clearance Summary
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM received FDA 510(k) clearance under submission number K112386, sponsored by Coloplast Corp.. 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 2011-09-08.
- Submission: K112386
- Applicant / Sponsor: Coloplast Corp.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.5980
- Decision date: 2011-09-08
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.