ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

K260521 · Zhuhai Pusen Medical Technology Co., Ltd. · FED · Apr 6, 2026 · Gastroenterology, Urology

Device Facts

• Record ID: K260521
• Device Name: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
• Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Apr 6, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

This device is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Device Story

Single-use ureteral access sheath; consists of guide sheath (with Y-type hub and sealing cap) and dilator. Inserted through natural urethra to establish conduit for endoscopic urological procedures. Facilitates passage of endoscopes and instruments into urinary tract. Used in hospitals or qualified medical institutions by clinicians. Device provides access; does not perform automated analysis or signal processing. Benefits include facilitated instrument access during urological procedures.

Clinical Evidence

Bench testing only. No clinical or animal studies performed. Bench testing included dimensions, surface inspection, compatibility/trafficability, deformation resistance, leakage, bending fatigue, friction coefficient, peak tensile force, and Luer connector testing. Biocompatibility testing conducted per ISO 10993-1:2018. All tests passed and met acceptance criteria.

Technological Characteristics

Single-use, EO-sterilized ureteral access sheath. Materials: Sheath tube (Copolyester, Polyether block polyamide, PTFE), Dilator (ABS, LDPE), Sealing cap/valve (Silicone rubber), Hydrophilic coating (PVP, PUA). Dimensions: 10Fr/12Fr ID, 40cm/50cm length. Mechanical features: Y-type hub, negative pressure valve. No electronic components, software, or energy source.

Indications for Use

Indicated for adults undergoing endoscopic urological procedures to establish a conduit for the passage of endoscopes and instruments into the urinary tract.

Regulatory Classification

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

• Disposable Ureteral Access Sheath (K243710)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 6, 2026

Zhuhai Pusen Medical Technology Co., Ltd.
Changshen Wang
RA&QA Director
# 1118, Jinrui Yi Rd., High-Tech Zone, 519085 Zhuhai, Guangdong, People's Republic Of China
Zhuhai, Guangdong 519085
CHINA

Re: K260521
Trade/Device Name: ClearEVAC Ureteral Aspirating Access Sheath
(PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FED
Dated: February 15, 2026
Received: February 17, 2026

Dear Changshen Wang:

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

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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

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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 ([e-mail]) or phone [phone] 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

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| 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. | K260521 | ? |
| Please provide the device trade name(s). | | ? |
| ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | | |
| Please provide your Indications for Use below. | | ? |
| This device is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. | | |
| 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) | ? |

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K260521
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

# 510(k) Summary

## I. SUBMITTER

Submitter's Name: Zhuhai Pusen Medical Technology Co, Ltd.
Submitter's Address: No. 1118, Jinrui Yi Road, High-tech Zone, Zhuhai, Guangdong 519085, PEOPLE’S REPUBLIC OF CHINA
Phone: [phone]
Contact Person: Ellen Wang
Date Prepared: 2026-03-27

## II. DEVICE

Trade Name: ClearEVAC Ureteral Aspirating Access Sheath
Common Name: Ureteral Access Sheath
Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Product Code: FED
Device Class: Class II
Regulation Name: Endoscope and Accessories
Regulation Number: 21 CFR 876.1500

## III. PREDICATE DEVICE

**Primary Predicate device**
Name of Device: Disposable Ureteral Access Sheath
510(k) number: K243710
Classification regulation: Endoscope and Accessories
Product code: FED
This predicate device has not been subject to a design-related recall.

## IV. DEVICE DESCRIPTION

This device is a single-use ureteral sheath, EO sterilized, provided sterile. It is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is intended to be inserted into the patient's body through natural urethra.

## V. INDICATIONS FOR USE

This device is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Section 5: 510(k) summary

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K260521
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

Patient population: It is designed for use in adults. Patients undergoing endoscopic procedures.

Use environment: This product is only for use in hospitals or qualified medical institutions.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The ClearEVAC Ureteral Aspirating Access Sheath is the same / similar to the predicate devices in the following areas:

Same:
- Indications for use;
- single use;
- Anatomical site;
- EO Sterilization.

Similarities:
- Structure

Differences:
- Sheath ID;
- Sheath Length;
- Shelf life.

| Description | Subject device | Predicate device | Discussion |
| --- | --- | --- | --- |
| Manufacturer | Zhuhai Pusen Medical Technology Co., Ltd. | Shenzhen Trious Medical Technology Co. Ltd . | N/A |
| Product Code | FED | FED | Same |
| Classification name | Endoscope and accessories | Endoscope and accessories | Same |
| Regulation Number | 21 CFR § 876.1500 | 21 CFR § 876.1500 | Same |
| 510(K) number | K260521 | K243710 | N/A |
| Trade name | ClearEVAC Ureteral Aspirating Access Sheath | Disposable Ureteral Access Sheath | N/A |
| Indications for use | This device is used to establish | The Disposable Ureteral Access Sheath | Similar. |

Section 5: 510(k) summary

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K260521
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

| Description | Subject device | Predicate device | Discussion |
| --- | --- | --- | --- |
| | a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. | is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract. | They are all used to establish access during endoscopic procedures in the urinary tract, differing only in descriptive terminology. this difference will not raise new questions of safety and effectiveness. |
| Regulatory Class | Class II | Class II | Same |
| Single Use | Yes | Yes | Same |
| Sterility | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
| Target population | Adults | Adults | Same |
| Anatomical site | Lower urinary tract. | Lower urinary tract. | Same |
| Use Environment | Hospital or qualified medical institution | Hospital environment or medical office environment. | Same |
| Patient Contacting Materials | Sheath tube: Copolyester Polyether block polyamide+Polytetrafluoroethylene
Dilator: ABS, Low density polyethylene
Sealing cap and Negative pressure valve Silicone rubber
Hydrophilic coating: PVP+PUA | Access sheath Tube body: PEBAX 6333 SA 01 MED, SUS 304, PTFE
Access sheath joint: ABS, PC (Pressure valve: ABS)
Silicone cap: silicone
Access sheath Tube body Coating: PVP | Different: The subject device ClearEVAC Ureteral Aspirating Access Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1", and it was concluded that the subject device is |

Section 5: 510(k) summary
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

| Description | Subject device | Predicate device | Discussion |
| --- | --- | --- | --- |
| | | Dilator tube body: LDPE
Dilator tube connector: HDPE | biological safe, therefore, this difference will not raise new questions of safety and effectiveness. |
| Sheath ID | 10Fr ,12Fr | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr | Different.
The predicate device is available in multiple sizes, and the inner diameter dimensions of the subject device fall within the size range of the predicate device, matching two of them exactly.
Different sheath inner diameter device will be selected by physician per patient's condition, this difference will not raise new questions of safety and effectiveness. |
| Sheath Length | 40cm, 50cm | 35cm, 40cm, 45cm, 50cm | Different.
The predicate device is available in multiple sizes, and the sheath length dimensions of the subject device fall within the size range of the predicate device, matching two of |

Section 5: 510(k) summary
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

| Description | Subject device | Predicate device | Discussion |
| --- | --- | --- | --- |
| | | | them exactly.
Different sheath length device will be selected by physician per patient's condition, this difference will not raise new questions of safety and effectiveness. |
| Primary Structure | This product consists of a guide sheath and a dilator.
The guide sheath is composed of a sheath, a sheath hub (Y-type joint) and a sealing cap.
The dilator has a dilator hub. | This product consists of access sheath and dilator tube. Z-type access sheath and T-type access sheath consist of tube body and straight joint; Y-type access sheath and W-type access sheath consist of tube body, Y-type joint and end cap; C type access sheath consists of tube body, W-type joint and end cap; the dilator tube consists of tube body and joint. | Similar.
Both the subject device and predicate device consist of a guide sheath and a dilator, the subject device has a Y-type joint, the predicate device include T, C,Z and Y type connectors. The Y type of the subject device is within the range of the predicate device. This difference will not raise new questions of safety and effectiveness. |

Section 5: 510(k) summary
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K260521
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

| Description | Subject device | Predicate device | Discussion |
| --- | --- | --- | --- |
| Bending Resistance/Toughness test | The tube body of the sheath and Dilator should have good toughness, and no permanent deformation should be produced when twisting 90° / 180°; After bending for 10 times and each maintained for 1 minute.(radius of curvature R=5 cm), the tube body shall not be creased or broken. | Fix the head end of the access sheath tube, dilator tube on a cylinder former with a radius of 5cm.wind the access sheath around the cylinder former for one circle ring and keep it for 1 min. Then release the wound access sheath tube. The tube body of the access sheath should remain intact without any deformations, cracks, folding, or other defective phenomena. | Similar.
Added a requirement that no permanent deformation should occur when twisted 90° /180°, with no other differences. This difference will not raise new questions of safety and effectiveness. |
| Coefficients of Friction | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | Same |
| Peak tensile force | The peak tension force measured between the sheath tube and the sheath, at the locking point of the sheath tube and dilator hub, and between the dilator hub and dilator tube shall each be no less than 15 N. | The minimum peak tensile force at the access sheath tube body, and at union of the access sheath tube body and the access sheath tube joint shall not be less than 15 N. | Similar.
Although the descriptions of each product component differ, the acceptance criteria for testing remain the same. This difference will not raise new questions of safety and effectiveness. |
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, Acute System | Cytotoxicity, Irritation, Sensitization, Acute | Same |

Section 5: 510(k) summary
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

| Description | Subject device | Predicate device | Discussion |
| --- | --- | --- | --- |
| | Toxicity, Material mediated pyrogencity | System Toxicity,Material mediated pyrogencity | |
| Shelf life | 2 years | 3 years | Different:
A claimed shelf life of either two years or three years is a well-established and widely accepted practice in the market. Besides, the shelf life of the subject device is sufficiently validated.

This difference will not raise new questions of safety and effectiveness. |

## VII. PERFORMANCE DATA

The ClearEVAC Ureteral Aspirating Access Sheath has been verified for the safety and effectiveness based on the following performance data.

## Biocompatibility testing

The biocompatibility evaluation for the ClearEVAC Ureteral Aspirating Access Sheath was conducted in accordance with the FDA final guidance “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"” (issued on September 4, 2020) and international standard ISO 10993-1:2018 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA.

For the Ureteral Aspirating Access Sheath, all evaluation acceptance criteria were met.

Section 5: 510(k) summary
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PUSEN
Zhuhai Pusen Medical Technology Co., Ltd.
Traditional 510(k)

# Performance Testing

- Bench Testing:
- Dimensions;
- Surface inspection
- Compatibility and Trafficability
- Deformation resistance
- Leakage test
- Bending fatigue test
- Friction coefficient
- Component peak tensile force
- Luer connectors

# Animal Study and Clinical Studies (Not applicable). Other study

- Shelf life study
- Sterilization validation

Summary of performance data

All tests were passed and all evaluation acceptance criteria were met.

# VIII. CONCLUSIONS

The performance data described above demonstrate that the ClearEVAC Ureteral Aspirating Access is as safe and effective as the predicate device and supports a substantial equivalence determination.

Section 5: 510(k) summary