Clearance Summary
PERCU GUIDE I (LOOP TYPE) received FDA 510(k) clearance under submission number K863090, sponsored by E-Z-Em, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1986-08-29.
- Submission: K863090
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-08-29
Classification & Regulation
This clearance is catalogued under FDA product code GDF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.