← Product Code [FAJ](/productcode/FAJ) · K253696 # CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) (K253696) _Verathon Medical (Canada) Ulc · FAJ · May 11, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253696 ## Device Facts - **Applicant:** Verathon Medical (Canada) Ulc - **Product Code:** [FAJ](/productcode/FAJ.md) - **Decision Date:** May 11, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The CFlex Single-use Cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via compatible Verathon monitor and can be used with endoscopic accessories. The cystoscope is intended for use in adults requiring cystoscopy by qualified urology professionals in a clinic, hospital or ambulatory surgery center (ASC) environment. The CystoView monitor is intended to display live imaging data from the CFlex Single-use Cystoscope. ## Device Story CFlex Single-use Cystoscope is a flexible, sterile, single-use endoscope featuring a distal CMOS camera, LED light source, and working channel; used with CystoView monitor. System captures live endoscopic video of lower urinary tract; transmits data to monitor for real-time visualization. Operated by urology professionals in clinics, hospitals, or ASCs. Monitor provides touchscreen interface for image/video management, storage, and transfer to USB. Integrated stopcock and flow control lever manage irrigation. Device supports use of endoscopic accessories, including electrosurgical tools. Output assists clinicians in visual diagnosis and procedural guidance during cystoscopy. Benefits include single-use sterility, reducing cross-contamination risk, and high-resolution visualization. ## Clinical Evidence No clinical studies were conducted. Substantial equivalence is supported by bench testing, including system verification (articulation, irrigation, working channel), software verification (IEC 62304), electrical safety (IEC 60601-1, 60601-2-18), EMC (IEC 60601-1-2), optical performance (ISO 8600 series), photobiological safety (IEC 62471), biocompatibility (ISO 10993-1), sterilization validation (ISO 11135), and usability (IEC 62366-1). ## Technological Characteristics Flexible endoscope with CMOS sensor (400x400px), LED illumination, and 2.4mm working channel. Sterilized via Ethylene Oxide (ETO). Monitor features 15.6" touchscreen, rechargeable Li-ion battery, and IP54 rating. Connectivity includes USB for data transfer. Compliant with IEC 60601-2-2 for electrosurgical compatibility. Materials validated per ISO 10993-1. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Predicate Devices - Ambu aScope 5 Cysto HD and aView 2 Advance Gen. 2 Monitor ([K240848](/device/K240848.md)) ## Reference Devices - Ambu aScope 4 Cysto ([K193095](/device/K193095.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 11, 2026 Verathon Medical (Canada) Ulc Curtis Jensen Sr. Regulatory Affairs Specialist 2227 Douglas Rd. Burnaby, BC V5C 5A9 CANADA Re: K253696 Trade/Device Name: CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, FET Dated: April 15, 2026 Received: April 16, 2026 Dear Curtis Jensen: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253696 - Curtis Jensen Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K253696 - Curtis Jensen Page 3 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mark R. Kreitz -S for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253696 | ? | | Please provide the device trade name(s). | | ? | | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | | | | Please provide your Indications for Use below. | | ? | | The CFlex Single-use Cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via compatible Verathon monitor and can be used with endoscopic accessories. The cystoscope is intended for use in adults requiring cystoscopy by qualified urology professionals in a clinic, hospital or ambulatory surgery center (ASC) environment. The CystoView monitor is intended to display live imaging data from the CFlex Single-use Cystoscope. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | {4} K253696 Page 1 of 4 verathon 510(k) Summary This summary of Safety and Effectiveness is provided as part of this Premarket Submission. Submitter: Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby, BC V5C 5A9 Canada Contact Person: Curtis Jensen Sr. Regulatory Affairs Specialist Phone: (425) 629-5530 Email: curtis.jensen@verathon.com Date Summary Prepared: April 15, 2026 Trade Name: CFlex Single-Use Cystoscope and CystoView Monitor Common/Usual name: Endoscope and Endoscope Video Imaging System/Component Classification Name: Endoscope and Accessories Regulation Number: 21 CFR 876.1500, Class II Classification Product Code: FAJ, FET Predicate Device: Ambu aScope 5 Cysto HD (Standard and Reverse Deflection) and aView 2 Advance Gen. 2 Monitor 510(k) # K240848 Reference Device: Ambu aScope 4 Cysto 510(k) # K193095 Review Panel: Reproductive, Gynecology and Urology Devices Device Description: The CFlex Single-use Cystoscope is an endoscope with a flexible shaft which houses a cylindrical working channel, components to allow the distal end to be articulated, and a high-resolution camera at the distal tip. Verathon Inc. Global Headquarters 20001 North Creek Parkway, Bothell, WA 98011 USA Tel-free: +1 800 331 2313 Tel: +1 425 867 1348 Verathon Medical (Canada) ULC 2227 Douglas Road, Burnaby, BC V5C 5A9 Canada Tel: +1 604 439 3009 verathon.com Page 1 | 4 {5} K253696 Page 2 of 4 The CystoView is a reusable single input monitor to be used for visualization when the CFlex is being used. The monitor contains proprietary Verathon operating software and a touchscreen display that serves as the user interface. The touchscreen display allows the user to display live and stored images/video, manage and transfer stored images/video to a USB drive, and customize settings. The monitor also incorporates an integrated cable holder to secure the compatible QuickConnect cable. The system also includes a rechargeable battery. ## Intended Use/Indications for Use: The CFlex Single-use Cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via compatible Verathon monitor and can be used with endoscopic accessories. The cystoscope is intended for use in adults requiring cystoscopy by qualified urology professionals in a clinic, hospital or ambulatory surgery center (ASC) environment. The CystoView monitor is intended to display live imaging data from the CFlex Single-use Cystoscope. ## Technological Comparison: The proposed subject CFlex Single-Use Cystoscope and CystoView Monitor when compared to the predicate Ambu aScope 5 Cysto HD and aView 2 Advance Gen. 2 Monitor has similar technological characteristics. See the comparison table below for similarities and differences between the proposed and predicate devices: | Technological Characteristic | Predicate Device Ambu aScope 5 Cysto HD and aView 2 Advance Gen. 2 Monitor (K240848) | Subject Device CFlex and CystoView (This submission) | | --- | --- | --- | | Flexible Endoscope | Yes | Yes | | Bending angle | 210° ± 15° up 120° down | 210° up 210° down | | Shaft outside diameter | 5.4 mm | 5.0 mm (15 Fr.) | | Maximum diameter of insertion portion | 6.0 mm | 5.7 mm (17.1 Fr.) | | Working Length | 388 mm | 390 mm | | Image sensor technology | CMOS (claimed “HD”) | CMOS (400x400px) | | Direction of view | 0° | Same | | Field of view | 120° Unknown | 120° (diagonal) 85° (horizontal/vertical) | | LED light source | Yes | Yes | | Min. working channel inner diameter | 2.2 mm (6.6 Fr.) | 2.4 mm (7.2 Fr.) | Page 2 | 4 {6} K253696 Page 3 of 4 | Technological Characteristic | Predicate Device Ambu aScope 5 Cysto HD and aView 2 Advance Gen. 2 Monitor (K240848) | Subject Device CFlex and CystoView (This submission) | | --- | --- | --- | | Method of sterilization for cystoscope | Ethylene Oxide (ETO) | Same | | Single-Use Cystoscope | Yes | Yes | | Control lever for tip maneuverability | Yes | Yes | | Camera | Yes | Yes | | Irrigation fluid flow control | Roller clamp or separately-purchased stopcock accessory | Integrated stopcock and fluid flow control lever | | Image display | Displays image on a reusable monitor | Same | | Image display size | 12.8" (diagonal) | 15.6 inch (diagonal) | | Power source | Rechargeable Lithium-Ion battery | Same | | IP Protection Classification – CystoView Monitor | IP31 | IP54 | | Compatibility with Endoscopic accessories and instruments | Irrigation set, Syringe and other Luer connecting accessories, endoscopic instruments labeled for use in a working channel size of (ID) 2.0mm/6.0 Fr or less, Access sheath with an inner diameter of no less than 20 Fr., Holmium YAG laser, Thulium fiber laser, high frequency surgical equipment fulfilling EN 60601-2-2 with a maximum sinusoidal voltage of the electrosurgical unit not exceeding 2.2 kVp | Irrigation set, Syringe and other Luer connecting accessories, endoscopic accessories labeled for use in a working channel size of (ID) 2.0mm/6.0 Fr or less, monopolar electrocautery tools used with the electrosurgical generators, both of which are certified as compliant with IEC 60601-2-2 with allowable voltage levels of the electrosurgical unit not exceeding the following: • Sinusoidal voltage: 2.2 kVpp • Cut: 1.1 kVp Coagulation: 2.4 kVp | ## Reference Device: Performance benchmark (comparative) testing was performed against the aScope 4 Cysto (K193095). ## Performance Testing: Performance testing has been completed to demonstrate that the proposed CFlex Cystoscope and CystoView Monitor meet the safety and performance requirements established in the design specifications. Comprehensive verification and validation testing included the following: Page 3 | 4 {7} K253696 Page 4 of 4 - System Verification testing including Articulation performance, Irrigation performance, Working Channel performance, High frequency tool activation compatibility performance - Software Verification testing according to IEC 62304 - Electrical Safety according to IEC 60601-1 and IEC 60601-2-18 - Electromagnetic Compatibility according to IEC 60601-1-2 - Optical performance testing including ISO 8600-1, ISO 8600-3 (Field of View and Direction of View), ISO 8600-4, Sharpness and Depth of Field, Geometric distortion, Color Performance, Noise Performance, Dynamic Range, Image Intensity Uniformity, Resolution - Photobiological safety according to IEC 62471 - Biocompatibility according to ISO 10993-1 including tests for: Cytotoxicity, Irritation, Sensitization, Material-mediated Pyrogenicity and Acute Systemic Toxicity - Sterilization validation according to ISO 11135 - Transportation Study according to ASTM D4169 - Stability study to document shelf life according to ASTM F1980 - Sterile Packaging Integrity Testing according to ISO 11607-1 - Cleaning Validation Testing - Design Validation according to IEC 62366-1 Results: All testing resulted in acceptance criteria passed. ## Comparative Testing: Comparative testing that was performed against the reference device included the following: - Field of View - Resolution (MTF/CTF) - Depth of Field - Signal to Noise Ratio - Geometric Distortion - Image Intensity Uniformity - Color performance. Results: The CFlex and CystoView were functionally equivalent to or better than the reference device. ## Summary of Clinical Tests: The CFlex Cystoscope and CystoView Monitor, subject of this submission, did not require clinical studies to support the determination of substantial equivalence. ## Conclusion: The information in this 510(k) Premarket Notification demonstrates that the proposed CFlex Single-Use Cystoscope and CystoView Monitor is substantially equivalent to the previously-cleared predicate Ambu aScope 5 Cysto HD and aView 2 Advance Gen. 2 Monitor with respect to safety, effectiveness, and performance. Page 4 | 4 --- **Source:** [https://fda.innolitics.com/device/K253696](https://fda.innolitics.com/device/K253696) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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