Clearance Summary
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family received FDA 510(k) clearance under submission number K191282, 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 2019-11-08.
- Submission: K191282
- 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: 2019-11-08
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.