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

Name: FDA 510(k) clearance K210116
Creator: U.S. Food and Drug Administration
Published: 2021-10-13

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.. Device class: 2.

Clearance details

Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
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 ↗

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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.