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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 the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-13 under 510(k) 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. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K210116.

When did Video Endoscopy System, 3D Video Endoscopy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Video Endoscopy System, 3D Video Endoscopy System?

The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Official Source

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

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