Clearance Summary
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT received FDA 510(k) clearance under submission number K971660, sponsored by Olympus America, Inc.. 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 1997-07-25.
- Submission: K971660
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-07-25
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.