FDA 510(k) Applications for Medical Device Product Code "FAJ"
(Cystoscope And Accessories, Flexible/Rigid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K042225 | ACMI CORPORATION | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | 09/10/2004 |
| K030960 | ACMI CORPORATION | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE | 07/16/2003 |
| K193095 | Ambu A/S | Ambu aScope 4 Cysto | 04/02/2020 |
| K160766 | AMBU A/S | Ambu USR, Ambu M | 08/17/2016 |
| K964037 | APPLIED FIBEROPTICS, INC. | FLEXIBLE CYSTOSCOPE | 02/20/1997 |
| K003988 | ARTES MEDICAL USA, INC. | UROSCOPE, ARTES MEDICAL, USA | 09/06/2001 |
| K031141 | ASAP ENDOSCOPIC PRODUCTS GMBH | ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE | 06/30/2003 |
| K093665 | BYRNE MEDICAL INC. | ENDO SMARTCAP | 12/15/2009 |
| K093725 | CANADA ENDOSCOPE CORPORATION | CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C | 08/30/2010 |
| K012929 | CIRCON VIDEO | FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 | 11/19/2001 |
| K000197 | CORTEK ENDOSCOPY, INC. | CORTEK CYSTOSCOPE | 03/03/2000 |
| K142194 | Emmy Medical | CytoSure Urinary Access System | 12/19/2014 |
| K970892 | FIEGERT, INC. | FIEGERT ENDOTECH CYSTOSCOPE | 05/05/1997 |
| K003807 | GLOBAL ENDOSCOPY, INC. | CYSTOSCOPES | 02/22/2001 |
| K090814 | GYRUS ACMI, INC. | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | 04/20/2009 |
| K171336 | Henke-Sass, Wolf GmbH | Cystoscope 4.0mm autoclavable 0░ WL 302mm; Hysteroscope 4.0mm autoclavable 0░ WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | 12/07/2017 |
| K221580 | Hunan Vathin Medical Instrument Co., Ltd. | Single-Use Flexible Cystoscope | 11/18/2022 |
| K992983 | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. | BAHO AUTOCLAVABLE CYSTOSCOPE | 10/07/1999 |
| K212476 | KARL STORZ Endoscopy America, Inc. | KARL STORZ Flexible HD Cysto-Urethroscope System | 09/03/2021 |
| K202957 | KARL STORZ Endoscopy-America, Inc | Flexible Video Cysto-Urethroscope (C-view) | 10/29/2020 |
| K182723 | KARL STORZ Endoscopy-America, Inc. | Flexible HD Cysto-Urethroscope System | 04/23/2019 |
| K191357 | KARL STORZ Endoscopy-America, Inc. | Flexible HD Cysto-Urethroscope System | 09/18/2019 |
| K992483 | MEDIFIX, INC. | MEDIFIX INC. | 08/30/1999 |
| K223926 | Medimaging Integrated Solution Inc. (MiiS) | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | 10/06/2023 |
| K223040 | Medivators Inc | Endo SmartCap | 03/01/2023 |
| K982620 | MEDIVISION SCOPE SERVICE CENTER, INC. | MEDIVISION CYSTOSCOPE | 09/30/1998 |
| K980592 | N-TECH ENDOSCOPY, INC. | NTECH CYSTOSCOPES | 04/28/1998 |
| K993689 | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | AED CYSTOSCOPE | 12/15/1999 |
| K021074 | OLYMPUS AMERICA, INC. | VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA | 05/02/2002 |
| K221690 | Olympus Medical Systems Corp. | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | 12/29/2022 |
| K221683 | Olympus Medical Systems Corporation | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) | 01/20/2023 |
| K212202 | OTU Medical INC. | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | 04/13/2022 |
| K231702 | OTU Medical Inc. | WiScope« Digital Cystoscope System, WiScope« Single-Use Digital Flexible Cystoscope, WiScope« Medical Tablet | 09/29/2023 |
| K960872 | POLLUX ENDOSCOPY, INC. | CYSTOSCOPE 0/15/30/70 DEGREES | 05/07/1996 |
| K120766 | PROSURG, INC. | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) | 09/11/2012 |
| K042780 | PROSURG, INC. | NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM | 02/03/2005 |
| K980401 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FLEXIBLE FIBERSCOPES AND ACCESSORIES | 05/21/1998 |
| K051176 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 | 10/05/2005 |
| K060899 | SCHOELLY IMAGING, INC. | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | 03/02/2007 |
| K222162 | Shanghai AnQing Medical Instrument Co., Ltd | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | 11/09/2022 |
| K033191 | SOHNIKS ENDOSCOPY, INC. | SOHNIKS | 03/09/2004 |
| K170862 | Solace Therapeutics, Inc. | Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope | 12/19/2017 |
| K043022 | Stryker Endoscopy | STRYKER FLEXIBLE CYSTONEPHROSCOPE | 03/15/2005 |
| K993041 | THE OLYMPUS OPTICAL CO. | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT | 03/30/2000 |
| K202921 | UroViu Corporation | Uro-G Cystoscope | 05/04/2021 |
| K182876 | UroViu Corporation | Uro-N Cystoscope | 07/02/2019 |
| K171500 | UroViu Corporation | Uro-V Cystoscope | 01/30/2018 |
| K181909 | UVision360 Inc. | Luminelle DTx Hysteroscopy System | 08/16/2018 |
| K210512 | Uvision360, Inc. | LUMINELLE DTx System | 06/30/2021 |
| K053560 | VISION-SCIENCES, INC. | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE | 03/16/2006 |
| K040215 | VISION-SCIENCES, INC. | VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM | 04/15/2004 |
| K072180 | VISION-SCIENCES, INC. | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | 12/18/2007 |
| K222602 | Zhuhai Pusen Medical Technology Co., Ltd. | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) | 09/26/2022 |
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