510(k) K241532— Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

Substantially Equivalent

Shanghai SeeGen Photoelectric Technology Co., Ltd.

Clearance details

Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-30
Decision date: 2024-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.