FDA Product Code
FDA Product Code FAJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 92 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | Olympus Winter & Ibe GmbH | 2026-05-21 | Traditional | PDF ↗ |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | Verathon Medical (Canada) Ulc | 2026-05-11 | Traditional | PDF ↗ |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA | 2026-04-16 | Traditional | PDF ↗ |
| K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | 2026-04-07 | Traditional | PDF ↗ |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. | 2026-03-27 | Traditional | PDF ↗ |
| K253226 | UV5000W Handle | Uroviu Corporation | 2025-10-23 | Special | PDF ↗ |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | 2025-09-23 | Traditional | PDF ↗ |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 | Special | PDF ↗ |
| K250797 | UV5000 Handle | Uroviu Corporation | 2025-09-11 | Traditional | PDF ↗ |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG | 2025-08-13 | Traditional | PDF ↗ |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 | Special | PDF ↗ |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | American Medical Endoscopy, Inc. | 2025-08-01 | Traditional | PDF ↗ |
| K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) | Ambu A/S | 2025-06-11 | Traditional | PDF ↗ |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 | Traditional | PDF ↗ |
| K243196 | Uro-G HD Cystoscope (1520) | Uroviu Corporation | 2024-12-13 | Special | PDF ↗ |
| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 | Ambu A/S | 2024-10-16 | Traditional | PDF ↗ |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S | 2024-10-10 | Traditional | PDF ↗ |
| K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | Lina Medical Aps | 2024-08-22 | Traditional | PDF ↗ |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-07-12 | Traditional | PDF ↗ |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-06-21 | Traditional | PDF ↗ |
| K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | MacroLux Medical Technology Co., Ltd. | 2024-06-10 | Traditional | PDF ↗ |
| K232837 | Uro-G HD Flexible Cystoscope | Uroviu Corporation | 2024-06-07 | Traditional | PDF ↗ |
| K231118 | Cystoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-11-13 | Traditional | PDF ↗ |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) | 2023-10-06 | Traditional | PDF ↗ |
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | OTU Medical, Inc. | 2023-09-29 | Traditional | PDF ↗ |
| K223040 | Endo SmartCap | Medivators, Inc. | 2023-03-01 | Special | PDF ↗ |
| K221683 | 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) | Olympus Medical Systems Corporation | 2023-01-20 | Traditional | PDF ↗ |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | Olympus Medical Systems Corp. | 2022-12-29 | Traditional | PDF ↗ |
| K221580 | Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 | Traditional | PDF ↗ |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-11-09 | Traditional | PDF ↗ |
| K222602 | 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) | Zhuhai Pusen Medical Technology Co., Ltd. | 2022-09-26 | Traditional | PDF ↗ |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | OTU Medical, Inc. | 2022-04-13 | Traditional | PDF ↗ |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | 2021-09-03 | Special | PDF ↗ |
| K210512 | LUMINELLE DTx System | Uvision360, Inc. | 2021-06-30 | Traditional | PDF ↗ |
| K202921 | Uro-G Cystoscope | Uroviu Corporation | 2021-05-04 | Traditional | PDF ↗ |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | KARL STORZ Endoscopy-America, Inc. | 2020-10-29 | Special | PDF ↗ |
| K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020-04-02 | Traditional | PDF ↗ |
| K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019-09-18 | Traditional | PDF ↗ |
| K182876 | Uro-N Cystoscope | Uroviu Corporation | 2019-07-02 | Traditional | PDF ↗ |
| K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019-04-23 | Traditional | PDF ↗ |
| K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | 2018-08-16 | Traditional | PDF ↗ |
| K171500 | Uro-V Cystoscope | Uroviu Corporation | 2018-01-30 | Traditional | PDF ↗ |
| K170862 | Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope | Solace Therapeutics, Inc. | 2017-12-19 | Traditional | PDF ↗ |
| K171336 | 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 | Henke-Sass, Wolf GmbH | 2017-12-07 | Traditional | PDF ↗ |
| K160766 | Ambu USR, Ambu M | Ambu A/S | 2016-08-17 | Traditional | PDF ↗ |
| K142194 | CytoSure Urinary Access System | Emmy Medical | 2014-12-19 | Traditional | PDF ↗ |
| K120766 | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) | Prosurg, Inc. | 2012-09-11 | Traditional | PDF ↗ |
| K093725 | CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C | Canada Endoscope Corporation | 2010-08-30 | Traditional | PDF ↗ |
| K093665 | ENDO SMARTCAP | Byrne Medical, Inc. | 2009-12-15 | Traditional | PDF ↗ |
| K090814 | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | Gyrus Acmi, Inc. | 2009-04-20 | Special | PDF ↗ |
| K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2007-12-18 | Traditional | PDF ↗ |
| K060899 | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | Schoelly Imaging, Inc. | 2007-03-02 | Traditional | PDF ↗ |
| K053560 | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE | Vision-Sciences, Inc. | 2006-03-16 | Special | PDF ↗ |
| K051176 | FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 | Richard Wolf Medical Instruments Corp. | 2005-10-05 | Traditional | PDF ↗ |
| K043022 | STRYKER FLEXIBLE CYSTONEPHROSCOPE | Stryker Endoscopy | 2005-03-15 | Traditional | PDF ↗ |
| K042780 | NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM | Prosurg, Inc. | 2005-02-03 | Traditional | PDF ↗ |
| K042225 | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | Acmi Corporation | 2004-09-10 | Special | PDF ↗ |
| K040215 | VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2004-04-15 | Traditional | PDF ↗ |
| K033191 | SOHNIKS | Sohniks Endoscopy, Inc. | 2004-03-09 | Traditional | PDF ↗ |
| K030960 | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE | Acmi Corporation | 2003-07-16 | Traditional | PDF ↗ |
| K031141 | ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE | Asap Endoscopic Products GmbH | 2003-06-30 | Traditional | PDF ↗ |
| K021074 | VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA | Olympus America, Inc. | 2002-05-02 | Special | PDF ↗ |
| K012929 | FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 | Circon Video | 2001-11-19 | Traditional | PDF ↗ |
| K003988 | UROSCOPE, ARTES MEDICAL, USA | Artes Medical USA, Inc. | 2001-09-06 | Traditional | PDF ↗ |
| K003807 | CYSTOSCOPES | Global Endoscopy, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT | The Olympus Optical Co. | 2000-03-30 | Traditional | PDF ↗ |
| K000197 | CORTEK CYSTOSCOPE | Cortek Endoscopy, Inc. | 2000-03-03 | Traditional | PDF ↗ |
| K993689 | AED CYSTOSCOPE | National Advanced Endoscopy Devices, Inc. | 1999-12-15 | Traditional | PDF ↗ |
| K992983 | BAHO AUTOCLAVABLE CYSTOSCOPE | Innovative Endoscopy Components, LLC | 1999-10-07 | Traditional | PDF ↗ |
| K992483 | MEDIFIX INC. | Medifix, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K982620 | MEDIVISION CYSTOSCOPE | Medivision Scope Service Center, Inc. | 1998-09-30 | Traditional | PDF ↗ |
| K980401 | FLEXIBLE FIBERSCOPES AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | 1998-05-21 | Traditional | PDF ↗ |
| K980592 | NTECH CYSTOSCOPES | N-Tech Endoscopy, Inc. | 1998-04-28 | Traditional | PDF ↗ |
| K970892 | FIEGERT ENDOTECH CYSTOSCOPE | Fiegert, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K964037 | FLEXIBLE CYSTOSCOPE | Applied Fiberoptics, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K960872 | CYSTOSCOPE 0/15/30/70 DEGREES | Pollux Endoscopy, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K953201 | IMAGYN UROSCOPE | Imagyn Medical, Inc. | 1995-08-02 | Traditional | PDF ↗ |
| K945262 | OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES | Optus, Inc. | 1995-05-26 | Traditional | PDF ↗ |
| K945527 | KARL STORZ TELESCOPE BRIDGES AND ADAPTERS | KARL STORZ Endoscopy-America, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K943176 | KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ | KARL STORZ Endoscopy-America, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K941779 | KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-06-27 | Traditional | PDF ↗ |
| K935278 | KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K930827 | BARD STABILIZING CANNULA | C.R. Bard, Inc. | 1993-05-14 | Traditional | PDF ↗ |
| K922320 | OMNI CYSTOSCOPE | Expanded Optics, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K914008 | PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P | Pentax Precision Instrument Corp. | 1992-01-10 | Traditional | PDF ↗ |
| K902274 | CUSTOMED CYSTO PACK I | Customed, Inc. | 1990-09-20 | Traditional | PDF ↗ |
| K895182 | ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY | Advanced Surgical Intervention, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K860822 | LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35 | Cooper Lasersonics, Inc. | 1986-04-17 | Traditional | PDF ↗ |
| K820851 | CURITY ECONOMY II CYSTOSCOPY TRAY | The Kendal Co. | 1982-05-13 | Traditional | PDF ↗ |
| K760189 | STOPCOCK, WATERLINE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 | Traditional | PDF ↗ |
| K760179 | SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 | Traditional | PDF ↗ |
| K760274 | TIP, RUBBER, PERFORATED | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 | Traditional | PDF ↗ |
Product code FAJ · Class II · Gastroenterology, Urology. Data: openFDA.