FDA.reportPublic FDA data

510(k) K233778

Device
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
Applicant
Zhuhai Pusen Medical Technology Co., Ltd.
510(k) number
K233778
Product code
FGB
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-16
Date received
2023-11-27
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
No

Applicant Contact#

Contact
Changshen Wang
Address
5/F, Bldg. 1, # 33, Ke Ji San Rd., High-Tech Zone, Tangjiawan Town Zhuhai CN 519000 519000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FGB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.2026-04-09
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K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG2025-11-18
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K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)Shanghai AnQing Medical Instrument Co., Ltd.2025-10-03
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
K250049Medical 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)Seplou (Zhuhai) Co., Ltd.2025-08-26
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