Two Channel Gastrofiberscope Fg-36T

K833924 is the FDA 510(k) clearance record for TWO CHANNEL GASTROFIBERSCOPE FG-36T, a class II device, cleared for Pentax Precision Instrument Corp. on 1984-02-04 under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid). FDA's definition for product code FDS reads: "To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available...". FDA records list 67 510(k) clearances for Pentax Precision Instrument Corp., from 1979-12-10 to 2004-06-09. As of 2026-09-10, FDA records show no recalls naming K833924.