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510(k) K181977

Device
WiScope Digital Endoscope System
Applicant
OTU Medical Inc.
510(k) number
K181977
Product code
FGB  
Decision
Substantially Equivalent (SESE)
Decision date
2018-08-14
Date received
2018-07-24
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
Yes

Applicant Contact#

Contact
Doris Dong
Address
2231 A Fortune Dr. San Jose CA US 95131 95131

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
K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.2026-07-20
K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.2026-04-09
K260013CVAC Image ProcessorCalyxo, Inc.2026-03-06
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
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
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

Legacy Summary#

summary

FDA Review#

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