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FDA 510(k)

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

K-Number: K250551 · 2025-10-02

ApplicantShenzhen Sophway Technology Co., Ltd.
Decision Date2025-10-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is a medical device manufactured by Shenzhen Sophway Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-02 under approval number K250551. 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 Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Shenzhen Sophway Technology Co., Ltd.. The 510(k) number is K250551.

When was 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) approved by the FDA?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) received FDA 510(k) clearance on 2025-10-02, under approval number K250551.

What company makes 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is manufactured by Shenzhen Sophway Technology Co., Ltd..

What is the FDA product code for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

The FDA product code for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is GCJ.

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Other Devices by Shenzhen Sophway Technology Co., Ltd.

K250204Endoscopic Camera System

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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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