The Flexible Suction Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. It is also used as a steerable ureteral catheter that establishes a conduit for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.

Device Description

The Flexible Suction Ureterorenoscope (Model: US27G-12-EU; US27G-12-US; US33G-17-EU; US33G-17-US; US38G-20-EU; US38G-20-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Suction Ureterorenoscope is also used as a steerable ureteral catheter. The Flexible Suction Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Suction Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is steered by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, optical fibers for transmitting illumination from the LED inside the Handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).

Mechanism of action:

The light emitted from the distal tip of the Flexible Suction Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope. The suction button enables aspiration through the working channel.

Flexible Suction Ureterorenoscope has the following physical and performance characteristics:

Steerable tip controlled by the user
Flexible insertion cord
Camera at the distal tip
LED in the handle and transmitted to the distal tip by optical fibers
Suction button and connector
Sterilized by Ethylene Oxide
For single use

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Flexible Suction Ureterorenoscope

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

October 3, 2025

Shanghai AnQing Medical Instrument Co., Ltd.
Shuwen Fan
3 & 4 Floor, No.2 Building, 366 Huiqing Rd
East Zhangjiang High-Tech Park
Shanghai, 201201
CHINA

Re: K252806
Trade/Device Name: Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FGB
Dated: September 3, 2025
Received: September 3, 2025

Dear Shuwen Fan:

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: 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, FDA may publish further announcements concerning your device in the Federal Register.

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K252806 - Shuwen Fan

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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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 Division of Industry and Consumer Education (DICE) to ask a question about a specific

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K252806 - Shuwen Fan

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 J. ANTONINO -S

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

Page 4

Indications for Use

K252806 Page 1 of 1

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

Please provide the device trade name(s).

Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Flexible Suction Ureterorenoscope Page 9 of 29

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510(k) Summary

K252806 Page 2 of 2

510(k)#: Prepared on: 2025-10-02

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Shanghai AnQing Medical Instrument Co., Ltd.
Applicant Address	3 & 4 Floor, No.2 Building, 366 Huiqing Rd, East Zhangjiang High-Tech Park Shanghai 201201 China
Applicant Contact Telephone	+86-21-61117375
Applicant Contact	Ms. Shuwen Fan
Applicant Contact Email	ra_dept@anqing-sh.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
Common Name	Endoscope and accessories
Classification Name	Ureteroscope And Accessories, Flexible/Rigid
Regulation Number	876.1500
Product Code(s)	FGB

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K243857	Flexible Ureterorenoscope	FGB

Device Description Summary

21 CFR 807.92(a)(4)

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K252806 Page 2 of 2

Mechanism of action:

Flexible Suction Ureterorenoscope has the following physical and performance characteristics:

Steerable tip controlled by the user
Flexible insertion cord
Camera at the distal tip
LED in the handle and transmitted to the distal tip by optical fibers
Suction button and connector
Sterilized by Ethylene Oxide
For single use

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject device's indications for use is similar to that of the predicate device, the difference is only supplementary descriptions to the suction access functionality which aligns with that of the reference device (Single Use Suction Access Ureteroscope, K233778), and this difference does not change the intended use of the subject device.

Technological Comparison

21 CFR 807.92(a)(6)

The subject and predicate device have the same fundamental technology, insertion section length, deflection, direction of view, depth of field, type of imager, number of uses and sterilization method.

The subject device differs from the predicate in sizes, field of view, suction functionality. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The subject device was designed to comply with applicable parts of ISO 8600. Optical measurements and physical performance tests were performed according to applicable part of ISO 8600 standard, including appearance, working length, working channel diameter, maximum insertion width, and field of view.

Mechanical characteristics were tested including suction rate and suction durability.

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Suction Ureterorenoscope is as safe, as effective, and performs as well as the legally marketed device identified above.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.