Clearance Summary
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) received FDA 510(k) clearance under submission number K200090, 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 2020-07-23.
- Submission: K200090
- 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: 2020-07-23
Classification & Regulation
This clearance is catalogued under FDA product code ODG and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.