Clearance Summary
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS received FDA 510(k) clearance under submission number K130006, sponsored by Cook Biotech Incorporated. 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 2013-04-05.
- Submission: K130006
- Applicant / Sponsor: Cook Biotech Incorporated
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.5980
- Decision date: 2013-04-05
Classification & Regulation
This clearance is catalogued under FDA product code PAI and 21 CFR 884.5980, within the Obstetrics/Gynecology review panel as a Class III device.