Clearance Summary
PENTAX XENON LIGHT SOURCE received FDA 510(k) clearance under submission number K921315, 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 1993-06-25.
- Submission: K921315
- 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: 1993-06-25
Classification & Regulation
This clearance is catalogued under FDA product code GCT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.