Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)— 510(k) K241956

Substantially Equivalent

Hunan Endoso Life Technology Co., Ltd.

FDA 510(k) clearance K241956 for Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2), Substantially Equivalent on 2025-01-22. Applicant: Hunan Endoso Life Technology Co., Ltd..

Clearance details

Applicant: Hunan Endoso Life Technology Co., Ltd.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-03
Decision date: 2025-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiangtan, 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.