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FDA 510(k)

4K UHD Laparoscope

K-Number: K203255 · 2021-02-24

ApplicantScivita Medical Technology Co., Ltd.
Decision Date2021-02-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4K UHD Laparoscope is a medical device manufactured by Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-24 under approval number K203255. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4K UHD Laparoscope?

4K UHD Laparoscope is a medical device that received FDA 510(k) clearance on 2021-02-24. It is manufactured by Scivita Medical Technology Co., Ltd.. The 510(k) number is K203255.

When was 4K UHD Laparoscope approved by the FDA?

4K UHD Laparoscope received FDA 510(k) clearance on 2021-02-24, under approval number K203255.

What company makes 4K UHD Laparoscope?

4K UHD Laparoscope is manufactured by Scivita Medical Technology Co., Ltd..

What is the FDA product code for 4K UHD Laparoscope?

The FDA product code for 4K UHD Laparoscope is GCJ.

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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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