Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)— 510(k) K233778

Substantially Equivalent

Zhuhai Pusen Medical Technology Co., Ltd.

FDA 510(k) clearance K233778 for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH), Substantially Equivalent on 2024-07-16. Applicant: Zhuhai Pusen Medical Technology Co., Ltd..

Clearance details

Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2023-11-27
Decision date: 2024-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.