Clearance Summary
REDTECH GIPC 2000 received FDA 510(k) clearance under submission number K004040, sponsored by Red-Tech, 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 2001-03-29.
- Submission: K004040
- Applicant / Sponsor: Red-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2001-03-29
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.