Fcn-15X, Fiber Choledochonephroscope

K951191 is the FDA 510(k) clearance record for FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE, a class II device, cleared for Pentax Precision Instrument Corp. on 1995-05-30 under FDA product code FBN (Choledochoscope And Accessories, Flexible/Rigid). FDA's definition for product code FBN reads: "to examine and perform procedures within the bile ducts. 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 one recall naming K951191.