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3D Video Endoscopy System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210116

by Surgnova Healthcare Technologies (zhejiang) Co., Ltd.

Identifiers

510(k) Number
K210116 FDA 510(k)
FDA Product Code
HET FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1720 FDA 510(k)
Regulation Number
884.1720 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 3D Video Endoscopy System is a medical device designed to deliver real 3D perception with two independent CMOS sensors. It is intended for use in endoscopic procedures to enhance visualization and precision. The system features unique Fog-proof technology to improve procedure safety and efficiency.

This integrated system is supplied by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. and has received FDA 510K clearance with the product code HET. The device is designed to offer operation convenience while saving space and maintaining cost effectiveness. It is authorized for use in obstetrics and gynecology procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3D Video Endoscopy System - Surgnova Healthcare Technologies, 3D Video Endoscopy System - Surgnova Healthcare Technologies, DeepEye EVS200 3D Video Endoscopy System - medical-xprt.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgnova Healthcare Technologies (zhejiang) Co., Ltd.

Sources (1)

  • FDA 510(k) K210116 24 fields · synced Sep 25, 2026