Clearance Summary
Smith & Nephew Tablet Application received FDA 510(k) clearance under submission number K190367, sponsored by Smith & Nephew. 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 2019-05-21.
- Submission: K190367
- Applicant / Sponsor: Smith & Nephew
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-05-21
Classification & Regulation
This clearance is catalogued under FDA product code QGY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.