BEUDAMED
    Product Code: FGB FDA class 2 21 CFR 876.1500

    Ureteroscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    The Flexible or Rigid Ureteroscope and Accessories is an endoscopic instrument used to perform diagnostic and therapeutic procedures within the urinary tract, including the ureter and renal pelvis, such as stone retrieval or biopsies. Validated reprocessing instructions and reprocessing validation data must be included in any 510(k) submission for reusable flexible endoscopes in this product code. It is classified as FDA Class 2, requiring 510(k) premarket clearance, with product code FGB, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology specialty.

    View on FDA
    510(k)s
    113
    FEI Numbers
    120
    Registration Numbers
    120
    Unique Applicants
    63
    Years Active
    45

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    Basic Information

    Product Code
    FGB
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 113 510(k) clearances via K numbers.

    K Number Device Name
    K252929 Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
    K260013 CVAC Image Processor
    K252468 Single-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)
    K251951 Single-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)
    K253411 Miniature Telescope for Urology (27033AA)
    K250917 Flexible 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)
    K252806 Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
    K252703 LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
    K250049 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)
    K243550 KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
    K242699 Flexible 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)
    K250785 Single-use Flexible Ureteroscope
    K243894 F88 URE-SD/RD Flexible Ureteroscope
    K243532 LumiRex Ureteroscope
    K243857 Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
    K243708 Urology 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.)
    K243155 Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
    K243117 Digital Video Processor
    K241956 Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
    K241434 Video Ureteroscope System
    K240074 Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)
    K240203 URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
    K242108 Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance
    K233700 Avicenna Roboflex
    K241945 KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
    K233372 KARL STORZ Fiber Telescopes for Urology
    K233778 Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
    K241639 Single-use Video Ureterorenoscope (SVU-220US)
    K241598 LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)
    K233630 Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
    K232911 KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
    K240374 Ureterorenoscope System
    K233275 RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
    K231135 Video Ureteroscope System
    K231774 CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
    K233645 StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
    K230475 Medical Video Endoscope System
    K223097 RenaNav Ureteroscope System
    K231878 Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
    K230200 Single-Use Flexible Ureteroscope
    K221158 Single-Use Video Flexible Ureterorenoscope System
    K223466 Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101
    K221515 StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
    K222737 Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
    K220159 Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
    K213334 Monarch Platform, Urology
    K211686 Flexible Video-Choledo-Cysto-Ureteroscope System
    K212458 Flexible Video-Uretero-Renoscope SSU System
    K211347 Uretero1 Ureteroscope System
    K210579 WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
    K201897 Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
    K200369 OES Elite Ureteroscopes and Accessories
    K201293 Ureterorenoscope System
    K183188 Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
    K181451 URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
    K181977 WiScope Digital Endoscope System
    K180367 Ureterorenoscope System
    K172246 OLYMPUS URF-V2/V2R
    K172298 OLYMPUS URF-P6/P6R
    K172098 Medical Video Endoscope System
    K171076 Medical Video Endoscope System
    K153049 LithoVue System
    K142556 Flexible Video-Uretero-Choledochoscope System
    K141250 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
    K131369 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
    K121112 STRYKER VIDEO URETEROSCOPE
    K111480 MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
    K062707 RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
    K062725 MAXIFLEX-SEMI FLEX SCOPE
    K052044 ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
    K043021 STRYKER URETEROSCOPE
    K033651 OLYMPUS VIDEO URETEROSCOPE, NTSC
    K031278 STRYKER FLEXIBLE URETEROSCOPE
    K023358 USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
    K012758 URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
    K011849 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
    K012951 APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
    K012925 DUR-8, MODELS DUR-8
    K011325 MEDIFIX URETEROSCOPE
    K003806 URETEROSCOPES
    K000200 CORTEK URETHEROSCOPE
    K992527 URETERO-RENOSCOPE
    K991178 FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
    K990050 URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
    K982905 MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
    K963855 12 URETEROSCOPES/URETERO-RENOSCOPES
    K970427 KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
    K964482 FLEXIBLE URETEROSCOPE
    K960323 KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
    K951855 ULTRATHIN URETEROSCOPES
    K941013 HMT ALEXCOPE
    K940464 KARL STORZ URETERO-RENOSCOPE/URETERSCOPE
    K925128 THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
    K926423 S/2(TM) STOPCOCK
    K926004 ENDOSCOPE AND ACCOSSORIES
    K923545 BARD 7 FR. FIBER OPTIC ASSEMBLY
    K920750 BARD URETEROSCOPE DEFLECTION MODULE
    K915458 URETEROSCOPE
    K914106 PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
    K911411 BARD 3000 PLUS URETEROSCOPY SYSTEM
    K904793 SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
    K902773 SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
    K901214 RIGID URETEROSCOPE
    K900813 BARD SHORT RIGID URETEROSCOPE
    K884153 CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
    K883110 BARD URETEROSCOPIC DEVICE
    K880802 SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
    K880801 SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
    K872282 FLEXIBLE URETEROSCOPE
    K862551 FUNS-10, FUNS-11
    K852888 OLYMPUS RIGID URETERORENOSCOPE
    K844143 OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE
    K811535 MODEL FUS-1, FLEXIBLE URETEROSCOPE

    FEI Numbers

    This FDA classification entry is associated with 120 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 120 registration numbers. Click on an entry to view related FDA registrations.