Clearance Summary
FG-36UX, FIBER ULTRASOUND GASTROSCOPE received FDA 510(k) clearance under submission number K010740, sponsored by Pentax Precision Instrument Corp.. 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 2001-04-17.
- Submission: K010740
- Applicant / Sponsor: Pentax Precision Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2001-04-17
Classification & Regulation
This clearance is catalogued under FDA product code ODG and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.