Clearance Summary
Intact Advance and Intact Excision XL, Intact BLES received FDA 510(k) clearance under submission number K142477, sponsored by Intact Medical Corporation. 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 2014-12-15.
- Submission: K142477
- Applicant / Sponsor: Intact Medical Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2014-12-15
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.