510(k) K250551— 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Substantially Equivalent

Shenzhen Sophway Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Sophway Technology Co., Ltd.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-25
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.