FDA.report

510(k) K250049

Device
Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)
Applicant
Seplou (Zhuhai) Co., Ltd.
510(k) number
K250049
Product code
FGB
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-26
Date received
2025-01-10
Regulation
876.1500
Classification name
Ureteroscope And Accessories, Flexible/Rigid
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
QingFu Zeng
Address
5th Floor, Bldg. 1, # 8, Keji 10th Rd., Tangjiawan Town, High-Tech Zone Zhuhai CN 519085 519085

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
06976358503866SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17
06976358502180SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17
06976358502173SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17
06976358502166SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17
06976358502159SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17
06976358502142SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17
06976358502135SEPLOUSEPLOU (ZHUHAI) CO.,LTD.2025-09-17

Other 510(k) Records For Product Code FGB

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K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)Boston Scientific Corporation2025-09-24
K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)Karl Storz SE & CO. KG2025-06-06
K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)Opcom Medical, Inc.2025-05-28
K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.2025-05-06
K243894F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.2025-05-02
K243532LumiRex UreteroscopeContra Healthcare Solutions, LLC2025-04-28
K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.2025-04-11
K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)Scivita Medical Technology Co., Ltd.2025-03-27