Clearance Summary
HandX Instrument - Monopolar Spatula received FDA 510(k) clearance under submission number K222011, sponsored by Human Xtensions , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-01-12.
- Submission: K222011
- Applicant / Sponsor: Human Xtensions , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-01-12
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.