Clearance Summary
INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 received FDA 510(k) clearance under submission number K984444, sponsored by Sandhill Scientific, Inc.. 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 1999-01-11.
- Submission: K984444
- Applicant / Sponsor: Sandhill Scientific, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1999-01-11
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.