Clearance Summary
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL received FDA 510(k) clearance under submission number K190805, sponsored by Pentax of 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 2019-12-20.
- Submission: K190805
- Applicant / Sponsor: Pentax of America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-12-20
Classification & Regulation
This clearance is catalogued under FDA product code PEA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.