Clearance Summary
EZ-SCOPE AN & EZ-SCOPE AN LITE received FDA 510(k) clearance under submission number K020643, sponsored by Health Policy Resorters Group, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-05-28.
- Submission: K020643
- Applicant / Sponsor: Health Policy Resorters Group, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2002-05-28
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.