K243535

Substantially Equivalent

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
Product code: FBN
Advisory panel: Gastroenterology, Urology
Date received: 2024-11-15
Decision date: 2025-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, CN

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.