Ec-384Otl, Video Colonscope

K961563 is the FDA 510(k) clearance record for EC-384OTL, VIDEO COLONSCOPE, a class II device, cleared for Pentax Precision Instrument Corp. on 1996-06-19 under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDF reads: "To examine or perform procedures in the colon or rectum 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...". 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 K961563.