Clearance Summary
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 received FDA 510(k) clearance under submission number K161055, sponsored by Fuji Dynamics , 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 2016-07-12.
- Submission: K161055
- Applicant / Sponsor: Fuji Dynamics , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2016-07-12
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.