Clearance Summary
G-Tech Wireless Patch System (WPS) received FDA 510(k) clearance under submission number K212954, sponsored by G-Tech Medical. 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 2022-01-10.
- Submission: K212954
- Applicant / Sponsor: G-Tech Medical
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1735
- Decision date: 2022-01-10
Classification & Regulation
This clearance is catalogued under FDA product code MYE and 21 CFR 876.1735, within the Gastroenterology, Urology review panel as a Class II device.