Clearance Summary
SmartSurgN Visualization System received FDA 510(k) clearance under submission number K213943, sponsored by Smartsurgn Incorporated. 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 2022-11-29.
- Submission: K213943
- Applicant / Sponsor: Smartsurgn Incorporated
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-11-29
Classification & Regulation
This clearance is catalogued under FDA product code OWN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.