Clearance Summary
MODIFICATION TO SYSTEM 83 PLUS received FDA 510(k) clearance under submission number K983017, 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 1998-09-22.
- Submission: K983017
- Applicant / Sponsor: Custom Ultrasonics
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1998-09-22
Classification & Regulation
This clearance is catalogued under FDA product code NVE and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.