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FDA 510(k)

Endoscopic Camera System

K-Number: K250204 · 2025-07-01

ApplicantShenzhen Sophway Technology Co., Ltd.
Decision Date2025-07-01
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Camera System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K250204. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscopic Camera System?

Endoscopic Camera System is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. The 510(k) number is K250204.

When did Endoscopic Camera System receive FDA 510(k) clearance?

Endoscopic Camera System received FDA 510(k) clearance on 2025-07-01, under 510(k) number K250204.

Who is the listed applicant for Endoscopic Camera System?

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 Endoscopic Camera System?

The FDA product code for Endoscopic Camera System is FET.

Related Clinical Trials

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.

NCT07289854Portable Endoscopic Camera System Using Modified Action Camera for Endoscopic Sinunasal ExaminationCOMPLETED

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.

K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Related Devices (Code: FET)

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.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm CorporationK242067VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EAOlympus Corporations of the Americas

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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