Disposable Stone Extraction Basket
Device Facts
| Record ID | K253056 |
|---|---|
| Device Name | Disposable Stone Extraction Basket |
| Applicant | Zhejiang Soudon Medical Technology Co., Ltd. |
| Product Code | LQR · Gastroenterology, Urology |
| Decision Date | Apr 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The device is used for the endoscopic removal of biliary stones and foreign bodies in the biliary system. The device is indicated for use in adult patient.
Device Story
Disposable stone extraction basket; used for endoscopic removal of biliary stones/foreign bodies. Device consists of stainless steel/nitinol basket at distal end of sheath with handle; basket extends/retracts via handle actuator. Operated by physician during endoscopic procedures. Device captures stones/foreign bodies within biliary system; facilitates removal. Not compatible with mechanical lithotripters. Single-use; EO sterilized.
Clinical Evidence
No clinical data. Bench testing only, including appearance, size, connecting performance, smoothness, Luer joint performance, flexibility, and stone capture performance. Biocompatibility per ISO 10993 and sterility per ISO 11135.
Technological Characteristics
Materials: Nitinol, stainless steel, PTFE, ABS, PVC, Silica gel. Principle: Mechanical basket capture. Form factor: Catheter sheath with handle-actuated basket. Sterilization: EO. Standards: ISO 10993 (biocompatibility), ISO 11135 (sterility).
Indications for Use
Indicated for endoscopic removal of biliary stones and foreign bodies in the biliary system in adult patients.
Regulatory Classification
Identification
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
Special Controls
*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Predicate Devices
- Disposable Stone Extraction Basket (K201509)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
April 3, 2026
Zhejiang Soudon Medical Technology Co., Ltd
% Nick Wang
RA Specialist
Shanghai Vanhe Consulting Co., Ltd
2F, Building No.1, 3938 Huqingping Road, Qingpu District
Shanghai, 201703
China
Re: K253056
Trade/Device Name: Disposable Stone Extraction Basket
Regulation Number: 21 CFR 876.5010
Regulation Name: Biliary Catheter And Accessories
Regulatory Class: Class II
Product Code: LQR
Dated: September 15, 2025
Received: September 22, 2025
Dear Nick 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: 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K253056 - Nick Wang
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 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-
{2}
K253056 - Nick Wang
Page 3
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,
ANTHONY LEE -S
Anthony Lee, Ph.D., MBA
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant 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. | K253056 | ? |
| Please provide the device trade name(s). | | ? |
| Disposable Stone Extraction Basket | | |
| Please provide your Indications for Use below. | | ? |
| The device is used for the endoscopic removal of biliary stones and foreign bodies in the biliary system.
The device is indicated for use in adult patient. | | |
| 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) | ? |
{4}
K253056
Page 1 of 4
510(k) Summary
Disposable Stone Extraction Basket
# 510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
## 5.1 Submitter
| Submitted by: | Zhejiang Soudon Medical Technology Co.,Ltd
Address: Room 302-1,Floor 3, Building 4, No.1 Nangonghe Road, Donghu Street, Linping District, Hangzhou, Zhejiang, China |
| --- | --- |
| Establishment Registration Number | 3025311469 |
| Contact Person: | Nick Wang
RA Specialist
Shanghai Vanhe Consulting Co., Ltd
Address: 2F, Building No.1, 3938 Huqingping Road, Qingpu District, Shanghai, China.
Phone: 0086-13585860297
Email: vanheconsulting@126.com, yuriy@soudonmed.com |
| Date Prepared: | September 15, 2025 |
## 5.2 Device
| Trade Name | Disposable Stone Extraction Basket |
| --- | --- |
| Device Name | Disposable Stone Extraction Basket |
| Common Name: | Disposable Stone Extraction Basket |
| Regulation Number: | 876.5010 |
| Regulation Description: | Biliary Catheter and Accessories |
| Regulatory Class: | Class II |
| Product Code: | LQR |
| Product Code Name | Dislodger, Stone, Biliary |
## 5.3 Predicate Device
| Trade Name: | Disposable Stone Extraction Basket |
| --- | --- |
| Device Name | Disposable Stone Extraction Basket |
| Common Name: | Disposable Stone Extraction Basket |
| 510(k) Number | K201509 |
| Regulation Number: | 876.5010 |
| Regulation Name: | Biliary Catheter and Accessories |
| Regulatory Class: | Class II |
| Product Code: | LQR |
{5}
K253056
Page 2 of 4
510(k) Summary
Disposable Stone Extraction Basket
Product Code Name: Dislodger, Stone, Biliary
## 5.4 Device Description
The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is extended out of or retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.
## 5.5 Statement of Intended Use
The device is used for the endoscopic removal of biliary stones and foreign bodies in the biliary system. The device is indicated for use in adult patient.
## 5.6 Comparison of Technology Characteristics
Our proposed device Disposable Stone Extraction Basket is substantially equivalent to the predicate device. The differences between the Disposable Stone Extraction Basket and the predicate device do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | | Proposed Device | Predicate device | Comparison |
| --- | --- | --- | --- | --- |
| Common name | | Disposable Stone Extraction Basket | Disposable Stone Extraction Basket | / |
| 510k submitter | | Zhejiang Soudon Medical Technology Co.,Ltd | Hangzhou AGS MedTech Co., Ltd. | / |
| 510k number | | / | K201509 | / |
| Intended Use | | The device is used for the endoscopic removal of biliary stones and foreign bodies in the biliary system. The device is indicated for use in adult patient. | The device is used for the endoscopic removal of biliary stones and foreign bodies. | Same |
| Technical | Basket length | 25mm/34mm/42mm/50mm | 20mm/40mm/50mm | Different. The basket length of proposed device is in the range of the predicate device. |
| | Insert portion of maximum width | 1.8mm, 2.4mm | 2.0mm, 2.8mm, 3.7mm | Different. The difference among the proposed device |
{6}
K253056
Page 3 of 4
510(k) Summary
Disposable Stone Extraction Basket
| Item | Proposed Device | Predicate device | Comparison |
| --- | --- | --- | --- |
| | | | and predicated device is acceptable by demonstrating in bench testing. |
| Biological | Materials or substances in contact with human | Nitinol, stainless steel, PTFE, ABS, PVC, Silica gel | Nitinol, stainless steel, PTFE |
| | Biocompatibility | ISO 10993-5:2009
ISO 10993-10:2021
ISO 10993-23:2021
ISO 10993-11:2017 | In Vitro Cytotoxicity Test
ISO 10993.5-2009;
Skin sensitization Test, Intracutaneous Reactivity Test ISO 10993.10-2010; |
The fundamental principle of operation for both the proposed device and predicate device are the same. There are differences in the proposed device and predicate device technology - Basket Length, Insert portion of maximum width and material. These differences between the Disposable Stone Extraction Basket and the predicate device were evaluated utilizing performance testing and do not raise any questions regarding its safety and effectiveness.
## 5.7 Applicable Guidance Document
NA
## 5.8 Performance Data
The Disposable Stone Extraction Basket meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). Nonclinical bench testing demonstrate that the Disposable Stone Extraction Basket meets the performance criteria required to fulfill the intended use of the device.
The following summarizes the non-clinical bench testing conducted:
- Appearance
- Size
- Connecting Performance
- Smoothness Performance
- Luhr Joint Performance
- Flexibility
- Stone Capture Performance
## 5.9 Clinical Test
No Clinical Study is included in this submission.
{7}
K253056
Page 4 of 4
510(k) Summary
Disposable Stone Extraction Basket
## 5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Zhejiang Soudon Medical Technology Co.,Ltd has demonstrated that proposed device Disposable Stone Extraction Basket is substantially equivalent to the predicate device.
