FDA.report

510(k) K252929

Device
Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
Applicant
Anhui Happiness Workshop Instruments Co., Ltd.
510(k) number
K252929
Product code
FGB
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-09
Date received
2025-09-15
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
Jamie Zhang
Address
1/F, 2/F, 3/F, Bldg. 2, Wisdom Industrial Park, 1300 Jiangqiao Rd., Bengshan District Bengbu CN 233000 233000

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FGB

510(k)DeviceApplicantDecision date
K260013CVAC Image ProcessorCalyxo, Inc.2026-03-06
K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.2025-12-16
K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.2025-12-16
K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG2025-11-18
K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)Shenzhen Sanping Image Technology Co., Ltd.2025-10-31
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
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