Cystoscope And Accessories, Flexible/Rigid
FDA product code FAJ · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To examine and perform 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).
92510(k) clearances
0PMA approvals
22recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 8
- Uroviu Corporation 7
- Ambu A/S 5
- Vision-Sciences, Inc. 3
- Guangzhou Red Pine Medical Instrument Co., Ltd. 3
- V. Mueller O.V. Baxter Healthcare Corp. 3
- Acmi Corporation 2
- Hunan Vathin Medical Instrument Co., Ltd. 2
- OTU Medical, Inc. 2
- Olympus Medical Systems Corp. 2
- Uvision360, Inc. 2
- Shanghai AnQing Medical Instrument Co., Ltd. 2
- Prosurg, Inc. 2
- American Medical Endoscopy, Inc. 2
- Richard Wolf Medical Instruments Corp. 2
- Olympus Winter & Ibe GmbH 1
- Applied Fiberoptics, Inc. 1
- Pollux Endoscopy, Inc. 1
- Pentax Precision Instrument Corp. 1
- Customed, Inc 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…FAJ · Traditional | Olympus Winter & Ibe GmbH | 05/21/2026SE |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse…FAJ · Traditional | Verathon Medical (Canada) Ulc | 05/11/2026SE |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…FAJ · Traditional | Strauss Surgical USA | 04/16/2026SE |
| K253905 | PrimeSight UltraView SystemFAJ · Traditional | Cogentix Medical, Inc. | 04/07/2026SE |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ · Traditional | American Medical Endoscopy, Inc. | 03/27/2026SE |
| K253226 | UV5000W HandleFAJ · Special | Uroviu Corporation | 10/23/2025SE |
| K251140 | Zenflow Spring ScopeFAJ · Traditional | Zenflow, Inc. | 09/23/2025SE |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special | Shanghai AnQing Medical Instrument Co., Ltd. | 09/15/2025SE |
| K250797 | UV5000 HandleFAJ · Traditional | Uroviu Corporation | 09/11/2025SE |
| K243653 | KARL STORZ HOPKINS Telescopes for UrologyFAJ · Traditional | Karl Storz SE & CO. KG | 08/13/2025SE |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)FAJ · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/08/2025SE |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope…FAJ · Traditional | American Medical Endoscopy, Inc. | 08/01/2025SE |
| K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | Ambu A/S | 06/11/2025SE |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…FAJ · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 12/18/2024SE |
| K243196 | Uro-G HD Cystoscope (1520)FAJ · Special | Uroviu Corporation | 12/13/2024SE |
| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | Ambu A/S | 10/16/2024SE |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | Ambu A/S | 10/10/2024SE |
| K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)FAJ · Traditional | Lina Medical Aps | 08/22/2024SE |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…FAJ · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 07/12/2024SE |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)FAJ · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 06/21/2024SE |
| K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…FAJ · Traditional | MacroLux Medical Technology Co., Ltd. | 06/10/2024SE |
| K232837 | Uro-G HD Flexible CystoscopeFAJ · Traditional | Uroviu Corporation | 06/07/2024SE |
| K231118 | Cystoscope SystemFAJ · Traditional | Shenzhen HugeMed Medical Technical Development… | 11/13/2023SE |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxFAJ · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2023SE |
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…FAJ · Traditional | OTU Medical, Inc. | 09/29/2023SE |
| K223040 | Endo SmartCapFAJ · Special | Medivators, Inc. | 03/01/2023SE |
| K221683 | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)…FAJ · Traditional | Olympus Medical Systems Corporation | 01/20/2023SE |
| K221690 | Oes Cystonephro Fiberscope (Olympus CYF-5), Oes Cystonephro Fiberscope (Olympus CYF-5R)…FAJ · Traditional | Olympus Medical Systems Corp. | 12/29/2022SE |
| K221580 | Single-Use Flexible CystoscopeFAJ · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 11/18/2022SE |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 11/09/2022SE |
| K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope:…FAJ · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 09/26/2022SE |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…FAJ · Traditional | OTU Medical, Inc. | 04/13/2022SE |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope SystemFAJ · Special | Karl Storz Endoscopy America, Inc. | 09/03/2021SE |
| K210512 | LUMINELLE DTx SystemFAJ · Traditional | Uvision360, Inc. | 06/30/2021SE |
| K202921 | Uro-G CystoscopeFAJ · Traditional | Uroviu Corporation | 05/04/2021SE |
| K202957 | Flexible Video Cysto-Urethroscope (C-view)FAJ · Special | KARL STORZ Endoscopy-America, Inc. | 10/29/2020SE |
| K193095 | Ambu aScope 4 CystoFAJ · Traditional | Ambu A/S | 04/02/2020SE |
| K191357 | Flexible HD Cysto-Urethroscope SystemFAJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/18/2019SE |
| K182876 | Uro-N CystoscopeFAJ · Traditional | Uroviu Corporation | 07/02/2019SE |
| K182723 | Flexible HD Cysto-Urethroscope SystemFAJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/23/2019SE |
| K181909 | Luminelle DTx Hysteroscopy SystemFAJ · Traditional | Uvision360, Inc. | 08/16/2018SE |
| K171500 | Uro-V CystoscopeFAJ · Traditional | Uroviu Corporation | 01/30/2018SE |
| K170862 | Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long…FAJ · Traditional | Solace Therapeutics, Inc. | 12/19/2017SE |
| K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm…FAJ · Traditional | Henke-Sass, Wolf GmbH | 12/07/2017SE |
| K160766 | Ambu USR, Ambu MFAJ · Traditional | Ambu A/S | 08/17/2016SE |
| K142194 | CytoSure Urinary Access SystemFAJ · Traditional | Emmy Medical | 12/19/2014SE |
| K120766 | Endoscopic Diagnostic & Treatment System (Modification)FAJ · Traditional | Prosurg, Inc. | 09/11/2012SE |
| K093725 | Cystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-CFAJ · Traditional | Canada Endoscope Corporation | 08/30/2010SE |
| K093665 | Endo SmartcapFAJ · Traditional | Byrne Medical, Inc. | 12/15/2009SE |
| K090814 | Modification to Gyrus Acmi Invisio Icn, Models ICN-0564 and ICN-0565FAJ · Special | Gyrus Acmi, Inc. | 04/20/2009SE |
| K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemFAJ · Traditional | Vision-Sciences, Inc. | 12/18/2007SE |
| K060899 | Flexilux II Cystoscope and HysteroscopeFAJ · Traditional | Schoelly Imaging, Inc. | 03/02/2007SE |
| K053560 | Modified Endosheath System for Vsi Flexible CystoscopeFAJ · Special | Vision-Sciences, Inc. | 03/16/2006SE |
| K051176 | Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066FAJ · Traditional | Richard Wolf Medical Instruments Corp. | 10/05/2005SE |
| K043022 | Stryker Flexible CystonephroscopeFAJ · Traditional | Stryker Endoscopy | 03/15/2005SE |
| K042780 | Neoscope - Endoscopic Diagnostic & Treatment SystemFAJ · Traditional | Prosurg, Inc. | 02/03/2005SE |
| K042225 | Acmi Invisio Icn, Models ICN-0564 and ICN-0565FAJ · Special | Acmi Corporation | 09/10/2004SE |
| K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-On Endosheath SystemFAJ · Traditional | Vision-Sciences, Inc. | 04/15/2004SE |
| K033191 | SohniksFAJ · Traditional | Sohniks Endoscopy, Inc. | 03/09/2004SE |
| K030960 | Ecn Electronic Video CystonephroscopeFAJ · Traditional | Acmi Corporation | 07/16/2003SE |
| K031141 | Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap OesophagoscopeFAJ · Traditional | Asap Endoscopic Products GmbH | 06/30/2003SE |
| K021074 | Visera Cystovideoscope Olympus Cyf Type V/VaFAJ · Special | Olympus America, Inc. | 05/02/2002SE |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735FAJ · Traditional | Circon Video | 11/19/2001SE |
| K003988 | Uroscope, Artes Medical, USAFAJ · Traditional | Artes Medical USA, Inc. | 09/06/2001SE |
| K003807 | CystoscopesFAJ · Traditional | Global Endoscopy, Inc. | 02/22/2001SE |
| K993041 | Olympus XCYF-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary EquipmentFAJ · Traditional | The Olympus Optical Co. | 03/30/2000SE |
| K000197 | Cortek CystoscopeFAJ · Traditional | Cortek Endoscopy, Inc. | 03/03/2000SE |
| K993689 | AED CystoscopeFAJ · Traditional | National Advanced Endoscopy Devices, Inc. | 12/15/1999SE |
| K992983 | Baho Autoclavable CystoscopeFAJ · Traditional | Innovative Endoscopy Components, LLC | 10/07/1999SE |
| K992483 | Medifix Inc.FAJ · Traditional | Medifix, Inc. | 08/30/1999SE |
| K982620 | Medivision CystoscopeFAJ · Traditional | Medivision Scope Service Center, Inc. | 09/30/1998SE |
| K980401 | Flexible Fiberscopes and AccessoriesFAJ · Traditional | Richard Wolf Medical Instruments Corp. | 05/21/1998SE |
| K980592 | Ntech CystoscopesFAJ · Traditional | N-Tech Endoscopy, Inc. | 04/28/1998SE |
| K970892 | Fiegert Endotech CystoscopeFAJ · Traditional | Fiegert, Inc. | 05/05/1997SE |
| K964037 | Flexible CystoscopeFAJ · Traditional | Applied Fiberoptics, Inc. | 02/20/1997SE |
| K960872 | Cystoscope 0/15/30/70 DegreesFAJ · Traditional | Pollux Endoscopy, Inc. | 05/07/1996SE |
| K953201 | Imagyn UroscopeFAJ · Traditional | Imagyn Medical, Inc. | 08/02/1995SE |
| K945262 | Optus Cystoscopes and Pediatric CystoscopesFAJ · Traditional | Optus, Inc. | 05/26/1995SE |
| K945527 | Karl Storz Telescope Bridges and AdaptersFAJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/23/1994SE |
| K943176 | Karl Storz Hopkins I&Ii/Oper/Autoclavable TelescopesqFAJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/21/1994SE |
| K941779 | Karl Storz 11274 Series Flexible FiberscopeFAJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/27/1994SE |
| K935278 | Karl Storz Fixed Magnification Telescope/Karl Storz Variable Magnification TelescopeFAJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/24/1994SE |
| K930827 | Bard Stabilizing CannulaFAJ · Traditional | C.R. Bard, Inc. | 05/14/1993SE |
| K922320 | Omni CystoscopeFAJ · Traditional | Expanded Optics, Inc. | 01/13/1993SE |
| K914008 | Pentax Cystofiberscope, Model FCY-15PFAJ · Traditional | Pentax Precision Instrument Corp. | 01/10/1992SE |
| K902274 | Customed Cysto Pack IFAJ · Traditional | Customed, Inc. | 09/20/1990SESK |
| K895182 | Asi Cystoscope Sheath, Grasping Forceps & For.BodyFAJ · Traditional | Advanced Surgical Intervention, Inc. | 10/24/1989SE |
| K860822 | Lasersonics Laser Cystoscope Model FCY-6-35FAJ · Traditional | Cooper Lasersonics, Inc. | 04/17/1986SE |
| K820851 | Curity Economy II Cystoscopy TrayFAJ · Traditional | The Kendal Co. | 05/13/1982SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760179 | Sheath, Cystourethroscope W/ ObturatorFAJ · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760274 | Tip, Rubber, PerforatedFAJ · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0692-2024 Class II | Model No. CYF-V2R, VISERA Cysto-Nephro VideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-0691-2024 Class II | Model No. CYF-V2, VISERA Cysto-Nephro VideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-0690-2024 Class II | Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-0689-2024 Class II | Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-0685-2024 Class II | Model No. CYF-5R, CystonephrofiberscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-0684-2024 Class II | Model No. CYF-5, CystonephrofiberscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-0331-2024 Class II | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-1234-2022 Class II | STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS…The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing… | Karl Storz Endoscopy | 05/03/2022Open, Classified |
| Z-1262-2022 Class II | Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may… | Olympus Corporation of the Americas | 04/20/2022Open, Classified |
| Z-1066-2022 Class II | 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | Karl Storz Endoscopy | 04/01/2022Open, Classified |
| Z-1778-2020 Class II | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-1777-2020 Class II | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-1776-2020 Class II | Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-1775-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-1774-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-1773-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-1772-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | Medivators, Inc. | 10/09/2019Terminated |
| Z-0615-2018 Class II | Video Cystoscope models ECY-1570 and ECY-1570KThe video cytoscopes lack 510(k) premarket notification clearance. | Pentax of America Inc | 07/13/2017Terminated |
| Z-2070-2016 Class II | Cystoscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-1407-2016 Class II | Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2678-2015 Class II | CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2558-2015 Class II | CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |