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Medical Video Endoscope [Standard Deflection] (URS3005) +6 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250049

by Seplou (Zhuhai) Co., Ltd.

Identifiers

510(k) Number
K250049 FDA 510(k)
FDA Product Code
FGB FDA 510(k)
Models / Variants
Medical Video Endoscope [Standard Deflection] (URS3005) FDA 510(k)
Medical Video Endoscope [Reverse Deflection] (URS3005E) FDA 510(k)
Medical Video Endoscope [Standard Deflection] (URS3006) FDA 510(k)
Medical Video Endoscope [Reverse Deflection] (URS3006E) FDA 510(k)
Medical Video Endoscope [Standard Deflection] (URS3016) FDA 510(k)
Medical Video Endoscope [Reverse Deflection] (URS3016E) FDA 510(k)
Image processor (DIS8000) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Medical Video Endoscope [Standard Deflection] (URS3005) +6 more models by Seplou (Zhuhai) Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 7 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Seplou (Zhuhai) Co., Ltd.

Sources (1)

  • FDA 510(k) K250049 24 fields · synced Jun 18, 2026