Clearance Summary
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD received FDA 510(k) clearance under submission number K180583, sponsored by Richard Wolf Medical Instruments Corporation. 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 2018-06-28.
- Submission: K180583
- Applicant / Sponsor: Richard Wolf Medical Instruments Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2018-06-28
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.