PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

K162447 is the FDA 510(k) clearance record for PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner, a class II device, cleared for Pentax of America, Inc. on 2017-04-13 under FDA product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology). FDA's definition for product code ODG reads: "To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a...". FDA records list 72 510(k) clearances for Pentax of America, Inc., from 2004-10-19 to 2025-12-16. As of 2026-09-10, FDA records show no recalls naming K162447.