Product Code: FAJ FDA class 2 21 CFR 876.1500

Cystoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology

The Cystoscope and Accessories (Flexible/Rigid) (product code FAJ) is an endoscopic instrument used to examine and perform procedures within the urinary tract, including the bladder and urethra. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. For reusable flexible endoscopes of this type, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

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510(k)s

FEI Numbers

136

Registration Numbers

136

Unique Applicants

Years Active

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Basic Information

Product Code: FAJ
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 92 510(k) clearances via K numbers.

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