Flexible Video-Choledochoscope System— 510(k) K222261

Substantially Equivalent

Shanghai SeeGen Photoelectric Technology Co., Ltd.

FDA 510(k) clearance K222261 for Flexible Video-Choledochoscope System, Substantially Equivalent on 2023-04-20. Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd..

Clearance details

Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-28
Decision date: 2023-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.