Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Shenzhen Sophway Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-01 under approval 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. It is manufactured by Shenzhen Sophway Technology Co., Ltd.. The 510(k) number is K250204.

When was Endoscopic Camera System approved by the FDA?

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

What company makes Endoscopic Camera System?

Endoscopic Camera System is manufactured by Shenzhen Sophway Technology Co., Ltd..

What is the FDA product code for Endoscopic Camera System?

The FDA product code for Endoscopic Camera System is FET.

Related Clinical Trials

NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING

Other Devices by Shenzhen Sophway Technology Co., Ltd.

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

Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation

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.

↑