ClearanceBrief
Panels › Gastroenterology, Urology › Product code FGB · Class 2

Ureteroscope And Accessories, Flexible/Rigid

Regulation 876.1500

12510(k)s in 12 months (120 all time)
1recalls in 12 months (28 all time)
26recalls that name a 510(k)
Get daily alerts for FGBSample briefCSV

Top companies in FGB

Company510(k)sRecalls
Karl Storz Endoscopy218
Boston Scientific Corporation61
KARL STORZ Endoscopy-America, Inc.70
Shanghai AnQing Medical Instrument Co., Ltd.60
C.R. Bard, Inc.50
Hunan Vathin Medical Instrument Co., Ltd.50
Richard Wolf Medical Instruments Corp.50
Circon Video40
Karl Storz SE & CO. KG40
Olympus Corporation of the Americas04
Decided510(k)Device and applicantCode
Oct 20, 2026K260708Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital F
Vein 360
FGB
Sep 15, 2026K261447CVAC® Aspiration System
Calyxo, Inc.
FGB
Sep 9, 2026K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FGB
Aug 26, 2026K261153LithoVue Elite Digital Flexible Ureteroscope System
Boston Scientific Corporation
FGB
Aug 14, 2026K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
Scivita Medical Technology Co., Ltd., CN
FGB
Aug 7, 2026K253505Zamenix™ P
Roen Surgical, Inc., KR
FGB
Jul 20, 2026K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
MacroLux Medical Technology Co., Ltd., CN
FGB
Apr 9, 2026K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
Anhui Happiness Workshop Instruments Co., Ltd., CN
FGB
Mar 6, 2026K260013CVAC Image Processor
Calyxo, Inc.
FGB
Dec 16, 2025K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Dig
Zhejiang Geyi Medical Instrument Co., Ltd., CN
FGB
Dec 16, 2025K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Proc
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FGB
Nov 18, 2025K253411Miniature Telescope for Urology (27033AA)
Karl Storz SE & CO. KG, DE
FGB
Oct 31, 2025K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope,
Shenzhen Sanping Image Technology Co., Ltd., CN
FGB
Oct 3, 2025K252806Flexible 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., CN
FGB
Sep 24, 2025K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elit
Boston Scientific Corporation
FGB
Aug 26, 2025K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medi
Seplou (Zhuhai) Co., Ltd., CN
FGB
Jun 6, 2025K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Karl Storz SE & CO. KG, DE
FGB
May 28, 2025K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH
Opcom Medical, Inc., TW
FGB
May 6, 2025K250785Single-use Flexible Ureteroscope
Hunan Vathin Medical Instrument Co., Ltd., CN
FGB
May 2, 2025K243894F88 URE-SD/RD Flexible Ureteroscope
Sg Endoscopy Pte, Ltd., SG
FGB
Apr 28, 2025K243532LumiRex Ureteroscope
Contra Healthcare Solutions, LLC
FGB
Apr 11, 2025K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
Shanghai AnQing Medical Instrument Co., Ltd., CN
FGB
Mar 27, 2025K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-
Scivita Medical Technology Co., Ltd., CN
FGB
Feb 11, 2025K243155Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Dongguan Zsr Biomedical Technology Company Limited, CN
FGB
Jan 29, 2025K243117Digital Video Processor
Hunan Vathin Medical Instrument Co., Ltd., CN
FGB
Jan 22, 2025K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR1
Hunan Endoso Life Technology Co., Ltd., CN
FGB
Oct 4, 2024K241434Video Ureteroscope System
Hunan Vathin Medical Instrument Co., Ltd., CN
FGB
Oct 4, 2024K240074Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR
Shenzhen Besdata Technology Co., Ltd., CN
FGB
Sep 5, 2024K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
Dyne Medical Group, Inc., KR
FGB
Aug 16, 2024K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance
Ambu A/S, DK
FGB
Aug 16, 2024K233700Avicenna Roboflex
Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi, TR
FGB
Aug 1, 2024K241945KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
Karl Storz SE & CO. KG, DE
FGB
Jul 25, 2024K233372KARL STORZ Fiber Telescopes for Urology
Karl Storz SE & CO. KG, DE
FGB
Jul 16, 2024K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
Zhuhai Pusen Medical Technology Co., Ltd., CN
FGB
Jul 1, 2024K241639Single-use Video Ureterorenoscope (SVU-220US)
Huger Medical Instrument Co., Ltd., CN
FGB
Jul 1, 2024K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue El
Boston Scientific Corporation
FGB
Jun 24, 2024K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
Ambu A/S, DK
FGB
Jun 10, 2024K232911KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-F
Karl Storz Endovision, Inc.
FGB
May 10, 2024K240374Ureterorenoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd., CN
FGB
Mar 25, 2024K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Revers
Gyrus Acmi, Inc.
FGB
Jan 17, 2024K231135Video Ureteroscope System
Hunan Vathin Medical Instrument Co., Ltd., CN
FGB
Jan 11, 2024K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B);
MacroLux Medical Technology Co., Ltd., CN
FGB
Dec 12, 2023K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
Boston Scientific Corporation -
FGB
Nov 3, 2023K230475Medical Video Endoscope System
Huger Medical Instrument Co., Ltd., CN
FGB
Jul 31, 2023K223097RenaNav Ureteroscope System
CenterPoint Systems, LLC
FGB
Jul 25, 2023K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexib
STERIS Corporation
FGB
May 18, 2023K230200Single-Use Flexible Ureteroscope
Hunan Vathin Medical Instrument Co., Ltd., CN
FGB
Mar 6, 2023K221158Single-Use Video Flexible Ureterorenoscope System
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FGB
Feb 17, 2023K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexib
STERIS Corporation
FGB
Feb 2, 2023K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, Lith
Boston Scientific Corporation
FGB

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.