Clearance Summary
FE-34TH, FIBER ESOPHAGOSCOPE received FDA 510(k) clearance under submission number K951198, 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 1995-05-30.
- Submission: K951198
- 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: 1995-05-30
Classification & Regulation
This clearance is catalogued under FDA product code GCL and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.