510(k) K242535— Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

Substantially Equivalent

Hunan Vathin Medical Instrument Co., Ltd.

Clearance details

Applicant: Hunan Vathin Medical Instrument Co., Ltd.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-08-26
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiangtan, CN

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.