Clearance Summary
Endofresh Digestive Endoscopy System received FDA 510(k) clearance under submission number K192704, sponsored by Huizhou Xzing Technology Co., Ltd.. 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 2020-09-02.
- Submission: K192704
- Applicant / Sponsor: Huizhou Xzing Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2020-09-02
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.