Clearance Summary
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS received FDA 510(k) clearance under submission number K083499, sponsored by Coloplast A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2009-05-08.
- Submission: K083499
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- 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.