Panels › Gastroenterology, Urology › Product code FGB · Class 2
Ureteroscope And Accessories, Flexible/Rigid
Regulation 876.1500
13510(k)s in 12 months (121 all time)
1recalls in 12 months (28 all time)
26recalls that name a 510(k)
Top companies in FGB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 2, 2023 | K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, Lith Boston Scientific Corporation | FGB |
| Oct 5, 2022 | K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) Shanghai AnQing Medical Instrument Co., Ltd., CN | FGB |
| Aug 26, 2022 | K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) Shanghai AnQing Medical Instrument Co., Ltd., CN | FGB |
| Apr 29, 2022 | K213334 | Monarch Platform, Urology Auris Health, Inc. | FGB |
| Feb 22, 2022 | K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System Shanghai SeeGen Photoelectric Technology Co., Ltd., CN | FGB |
| Jan 20, 2022 | K212458 | Flexible Video-Uretero-Renoscope SSU System Karl Storz Endoscopy America | FGB |
| Nov 23, 2021 | K211347 | Uretero1 Ureteroscope System STERIS Corporation | FGB |
| Jul 22, 2021 | K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System OTU Medical, Inc. | FGB |
| Jan 15, 2021 | K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 Richard Wolf Medical Instruments Corporation | FGB |
| Aug 28, 2020 | K200369 | OES Elite Ureteroscopes and Accessories Olympus Winter & Ibe GmbH, DE | FGB |
| Jul 24, 2020 | K201293 | Ureterorenoscope System Shanghai AnQing Medical Instrument Co., Ltd., CN | FGB |
| May 3, 2019 | K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF Richard Wolf Medical Instruments Corporation | FGB |
| Jan 16, 2019 | K181451 | URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R Olympus Medical Systems Corp., JP | FGB |
| Aug 14, 2018 | K181977 | WiScope Digital Endoscope System OTU Medical, Inc. | FGB |
| Jul 3, 2018 | K180367 | Ureterorenoscope System Shanghai AnQing Medical Instrument Co., Ltd., CN | FGB |
| Mar 30, 2018 | K172246 | OLYMPUS URF-V2/V2R Olympus Medical Systems Corp., JP | FGB |
| Mar 29, 2018 | K172298 | OLYMPUS URF-P6/P6R Olympus Medical Systems Corp., JP | FGB |
| Aug 31, 2017 | K172098 | Medical Video Endoscope System Zhuhai Pusen Medical Technology Co., Ltd., CN | FGB |
| May 5, 2017 | K171076 | Medical Video Endoscope System Zhuhai Pusen Medical Technology Co., Ltd., CN | FGB |
| Nov 13, 2015 | K153049 | LithoVue System Boston Scientific Corporation | FGB |
| Oct 23, 2014 | K142556 | Flexible Video-Uretero-Choledochoscope System KARL STORZ Endoscopy-America, Inc. | FGB |
| Jun 11, 2014 | K141250 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. | FGB |
| Nov 26, 2013 | K131369 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. | FGB |
| Sep 12, 2012 | K121112 | STRYKER VIDEO URETEROSCOPE Stryker Endoscopy | FGB |
| Apr 4, 2012 | K111480 | MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM Technology Delivery Systems, Inc. | FGB |
| Dec 8, 2006 | K062707 | RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE Innovative Endoscopy Components, LLC | FGB |
| Sep 29, 2006 | K062725 | MAXIFLEX-SEMI FLEX SCOPE Technology Delivery Systems, Inc. | FGB |
| Aug 16, 2005 | K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL Acmi Corporation | FGB |
| Mar 16, 2005 | K043021 | STRYKER URETEROSCOPE Stryker Endoscopy | FGB |
| Jan 30, 2004 | K033651 | OLYMPUS VIDEO URETEROSCOPE, NTSC Olympus Winter & Ibe GmbH | FGB |
| Oct 16, 2003 | K031278 | STRYKER FLEXIBLE URETEROSCOPE Stryker Endoscopy | FGB |
| Jan 3, 2003 | K023358 | USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 Acmi Corporation | FGB |
| Apr 9, 2002 | K012758 | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, Circon Video | FGB |
| Dec 10, 2001 | K011849 | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS Circon Video | FGB |
| Nov 9, 2001 | K012951 | APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE Circon Video | FGB |
| Nov 7, 2001 | K012925 | DUR-8, MODELS DUR-8 Circon Video | FGB |
| Jul 25, 2001 | K011325 | MEDIFIX URETEROSCOPE Medifix, Inc. | FGB |
| Feb 22, 2001 | K003806 | URETEROSCOPES Global Endoscopy, Inc. | FGB |
| Mar 3, 2000 | K000200 | CORTEK URETHEROSCOPE Cortek Endoscopy, Inc. | FGB |
| Oct 13, 1999 | K992527 | URETERO-RENOSCOPE Fiber Imaging Technologies, Inc. | FGB |
| Jun 11, 1999 | K991178 | FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 Richard Wolf Medical Instruments Corp. | FGB |
| Mar 26, 1999 | K990050 | URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 Richard Wolf Medical Instruments Corp. | FGB |
| Oct 5, 1998 | K982905 | MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE Karl Storz Endoscopy | FGB |
| Apr 3, 1997 | K963855 | 12 URETEROSCOPES/URETERO-RENOSCOPES Richard Wolf Medical Instruments Corp. | FGB |
| Mar 11, 1997 | K970427 | KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE Karl Storz Endoscopy | FGB |
| Jan 24, 1997 | K964482 | FLEXIBLE URETEROSCOPE Applied Fiberoptics, Inc. | FGB |
| Apr 22, 1996 | K960323 | KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE KARL STORZ Endoscopy-America, Inc. | FGB |
| Aug 16, 1995 | K951855 | ULTRATHIN URETEROSCOPES Olympus America, Inc. | FGB |
| Feb 9, 1995 | K941013 | HMT ALEXCOPE Servicetrends, Inc. | FGB |
| Jun 24, 1994 | K940464 | KARL STORZ URETERO-RENOSCOPE/URETERSCOPE KARL STORZ Endoscopy-America, Inc. | FGB |
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