Clearance Summary
SERIES 400 GASTROENTEROLOGY SYSTEM received FDA 510(k) clearance under submission number K944620, sponsored by Marks & Murase. 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 1995-04-27.
- Submission: K944620
- Applicant / Sponsor: Marks & Murase
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1995-04-27
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.