Clearance Summary
Q-TIPS received FDA 510(k) clearance under submission number K770433, sponsored by Chesebrough-Pond'S U.S.A. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1977-04-15.
- Submission: K770433
- Applicant / Sponsor: Chesebrough-Pond'S U.S.A. Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6025
- Decision date: 1977-04-15
Classification & Regulation
This clearance is catalogued under FDA product code KXF and 21 CFR 880.6025, within the General Hospital review panel as a Class I device.