Clearance Summary
ENDOCAM Flex HD Camera System 5521 received FDA 510(k) clearance under submission number K161204, 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 2017-01-11.
- Submission: K161204
- 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: 2017-01-11
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.