Clearance Summary
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM received FDA 510(k) clearance under submission number K093312, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-12-08.
- Submission: K093312
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2009-12-08
Classification & Regulation
This clearance is catalogued under FDA product code KGC and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.