Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)— 510(k) K250124

Substantially Equivalent

Hangzhou Viction Medical Technology Co.,Ltd

FDA 510(k) clearance K250124 for Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532), Substantially Equivalent on 2025-08-06. Applicant: Hangzhou Viction Medical Technology Co.,Ltd.

Clearance details

Applicant: Hangzhou Viction Medical Technology Co.,Ltd
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-17
Decision date: 2025-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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.