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FDA 510(k)

Video Endoscopy System, 3D Video Endoscopy System

K-Number: K210116 · 2021-10-13

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2021-10-13
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Video Endoscopy System, 3D Video Endoscopy System is a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-13 under approval number K210116. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Video Endoscopy System, 3D Video Endoscopy System?

Video Endoscopy System, 3D Video Endoscopy System is a medical device that received FDA 510(k) clearance on 2021-10-13. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K210116.

When was Video Endoscopy System, 3D Video Endoscopy System approved by the FDA?

Video Endoscopy System, 3D Video Endoscopy System received FDA 510(k) clearance on 2021-10-13, under approval number K210116.

What company makes Video Endoscopy System, 3D Video Endoscopy System?

Video Endoscopy System, 3D Video Endoscopy System is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

What is the FDA product code for Video Endoscopy System, 3D Video Endoscopy System?

The FDA product code for Video Endoscopy System, 3D Video Endoscopy System is HET.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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