Clearance Summary
HD-Camera HDC1000 received FDA 510(k) clearance under submission number K152109, sponsored by W.O.M. World of Medicine GmbH. 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 2015-10-13.
- Submission: K152109
- Applicant / Sponsor: W.O.M. World of Medicine GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2015-10-13
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.