Clearance Summary
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) received FDA 510(k) clearance under submission number K080878, sponsored by Medical Technologies of Georgia, Inc.. 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 2008-07-17.
- Submission: K080878
- Applicant / Sponsor: Medical Technologies of Georgia, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2008-07-17
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.