Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models Mr-9, Mr-9L,

K012758 is the FDA 510(k) clearance record for URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,, a class II device, cleared for Circon Video on 2002-04-09 under FDA product code FGB (Ureteroscope And Accessories, Flexible/Rigid). FDA's definition for product code FGB reads: "To perform various diagnostic and therapeutic 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)...". FDA records list 14 510(k) clearances for Circon Video, from 1990-02-06 to 2002-04-09. As of 2026-09-10, FDA records show no recalls naming K012758.