Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

K233778 is the FDA 510(k) clearance record for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH), a class II device, cleared for Zhuhai Pusen Medical Technology Co., Ltd. on 2024-07-16 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 7 510(k) clearances for Zhuhai Pusen Medical Technology Co., Ltd., from 2017-05-05 to 2026-04-06. As of 2026-09-10, FDA records show no recalls naming K233778.