Clearance Summary
SYSTEM 83 PLUS received FDA 510(k) clearance under submission number K122172, sponsored by Custom Ultrasonics. 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 2013-01-25.
- Submission: K122172
- Applicant / Sponsor: Custom Ultrasonics
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2013-01-25
Classification & Regulation
This clearance is catalogued under FDA product code FEB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.