Cleared Traditional

K250204 - Endoscopic Camera System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250204 · Shenzhen Sophway Technology Co., Ltd. · General & Plastic Surgery device
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Jul 2025
Decision
158d
Days
Class 2
Risk

K250204 is an FDA 510(k) clearance for the Endoscopic Camera System. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Shenzhen Sophway Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2025 after a review of 158 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Sophway Technology Co., Ltd. devices

Submission Details

510(k) Number K250204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2025
Decision Date July 01, 2025
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 114d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Eva Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 97
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K250204.
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Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Feb 2025
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K241532 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Oct 2024