Clearance Summary
INSERTEASE received FDA 510(k) clearance under submission number K092829, sponsored by Christcot Medical Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-12-02.
- Submission: K092829
- Applicant / Sponsor: Christcot Medical Company
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 2009-12-02
Classification & Regulation
This clearance is catalogued under FDA product code OOW and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.