Video Endoscopy System, 3D Video Endoscopy System— 510(k) K210116

Substantially Equivalent

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

FDA 510(k) clearance K210116 for Video Endoscopy System, 3D Video Endoscopy System, Substantially Equivalent on 2021-10-13. Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

Clearance details

Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2021-01-19
Decision date: 2021-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.