FGB
Medical Video Endoscope System
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 113
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FGB
1–100 of 113- K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
- K260013 — CVAC Image Processor
- 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)
- 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)
- 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)
- 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)
- K241434 — Video Ureteroscope System
- K240203 — URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
- K233700 — Avicenna Roboflex
- K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance
- 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)
- 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)
- K241639 — Single-use Video Ureterorenoscope (SVU-220US)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.