4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
K-Number: K250551 · 2025-10-02
Device Summary
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. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. The 510(k) number is K250551.
When did 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) receive FDA 510(k) clearance?
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) received FDA 510(k) clearance on 2025-10-02, under 510(k) number K250551.
Who is the listed applicant for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?
The FDA 510(k) record lists Shenzhen Sophway Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Shenzhen Sophway Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GCJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.