Clearance Summary
FG-36UX FIBER ULTRASOUND GASTROSCOPE received FDA 510(k) clearance under submission number K041396, sponsored by Pentax Precision Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-06-09.
- Submission: K041396
- Applicant / Sponsor: Pentax Precision Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2004-06-09
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.