Pentax Cystofiberscope, Model Fcy-15P

K914008 is the FDA 510(k) clearance record for PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P, a class II device, cleared for Pentax Precision Instrument Corp. on 1992-01-10 under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAJ reads: "To examine and perform procedures within the urinary tract. 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 K914008.