Endoscopic Camera System— 510(k) K250204

Name: FDA 510(k) clearance K250204
Creator: U.S. Food and Drug Administration
Published: 2025-07-01

Substantially Equivalent

Shenzhen Sophway Technology Co., Ltd.

FDA 510(k) clearance K250204 for Endoscopic Camera System, Substantially Equivalent on 2025-07-01. Applicant: Shenzhen Sophway Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Sophway Technology Co., Ltd.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-24
Decision date: 2025-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM012026-07-02
K261260 — HD Camera Head OLYMPUS CH-S200-08-LB2026-06-24
K251734 — ProVee Video Processing Unit (PV-003)2025-09-24
K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K)2025-08-11

More clearances from Shenzhen Sophway Technology Co., Ltd.

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K250551 — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)2025-10-02

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.