Sphincterotome

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 21, 2026 Taewoong Medical Co., Ltd. % Matthew Krueger Principal Consultant Biologics Consulting Group, Inc. 100 Daingerfield Rd. Suite 101 Alexandria, Virginia 22314 Re: K260962 Trade/Device Name: Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: March 23, 2026 Received: March 23, 2026 Dear Matthew Krueger: 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} K260962 - Matthew Krueger 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} K260962 - Matthew Krueger 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. | K260962 | ? | | Please provide the device trade name(s). | | ? | | Sphincterotome | | | | Please provide your Indications for Use below. | | ? | | Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium. | | | | 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} 510(k) Summary Taewoong Medical K260962 Page 1 of 7 # 1. SUBMITTER INFORMATION Applicant: Taewoong Medical Contact: Yongjin Jeff Kim Phone: +82 70 4649 1543 Email: jinjeff@stent.net Address: 14, Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, 10022, Republic of Korea # 2. CORRESPONDENT INFORMATION Contact: Matthew Krueger Title: Principal Consultant Firm: Biologics Consulting Group Phone: (667) 352-2578 Email: mkrueger@biologicsconsulting.com Address: 100 Daingerfield Rd., Suite 101 Alexandria, VA 22314 # 3. DATE PREPARED: MARCH 20, 2026 # 4. DEVICE INFORMATION Device Name: Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories. Product Code: KNS Regulatory Class: Class II # 5. PREDICATE DEVICE INFORMATION Primary Predicate Device Name: Autotome™ Pro RX 39 Sphincterotome/Autotome™ Pro RX 44 Sphincterotome 510(k) Number: K232162 Manufacturer: Boston Scientific Corporation Page 1 of 7 {5} 510(k) Summary Taewoong Medical K260962 Page 2 of 7 Secondary Predicate Device Name: Autotome™ RX Model 510(k) Number: K013153 Manufacturer: Boston Scientific Corporation ## 6. DEVICE DESCRIPTION The Sphincterotome is an endoscopic electrosurgical accessory and consists of three parts: a cutting wire, a sheath, and a handle. The cutting wire is insulated with a non-conductive polymer tube and features a pre-curved and tapered tip. The sheath is made of a three-lumen polymer tube: one lumen for a cutting wire that transmits high-frequency current to the target site, another lumen for delivering contrast agents or saline, and the third lumen for introducing a guidewire. The proximal end of the sheath and cutting wire assembly terminates in a handle. The handle includes three parts: a plug that transmits high frequency electric current from the ESU to the cutting wire, an injection port, and a guidewire port. Physicians can manipulate the cutting wire by rotating the handle during the procedure. ## 7. INDICATIONS FOR USE Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium. ## 8. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Page 2 of 7 {6} 510(k) Summary Taewoong Medical K260962 Page 3 of 7 Table 1 provides the technological comparison. Page 3 of 7 {7} 510(k) Summary Taewoong Medical K260962 Page 4 of 7 Table 1: Technological Comparison to Predicate Devices | | Subject Device | Primary Predicate Device (K232162) | Secondary Predicate Device (K013153) | | --- | --- | --- | --- | | Device Name | Sphincterotome | Autotome™ Pro RX 39 Sphincterotome Autotome™ Pro RX 44 Sphincterotome | Autotome™ RX Model | | Common Name | Sphincterotome | Sphincterotome | Sphincterotome | | Manufacturer | Taewoong Medical | Boston Scientific | Boston Scientific | | Clinical Condition | An incision of papilla | An incision of papilla | An incision of papilla | | Application | Common Bile Duct, Papilla of Vater and/or Sphincter of Oddi | Common Bile Duct, Papilla of Vater and/or Sphincter of Oddi | Papilla of Vater and/or Sphincter of Oddi | | Procedure | Endoscopic | Endoscopic | Endoscopic | | Size Specification | - Distal tip O.D.: 1.6 mm - Tip length: 7 mm - Cutting wire length: 20/25/30 mm - Length: 1950 mm | - Distal tip O.D.: 1.47 (4.4Fr) mm - Tip length: 5 mm - Cutting wire length: 25 mm - Length: 2000 mm | - Distal tip O.D.: 1.3 (3.9Fr) / 1.47 (4.4Fr) / 1.63 (4.9Fr) mm - Tip length: 5 mm - Cutting wire length: 20 / 30 mm - Length: 2000 mm | | Materials | - Cutting wire: SUS304 - Sheath: PTFE tube - Handle: ABS | - Cutting wire: Metal - Sheath: Polymer | - Cutting wire: Metal - Sheath: Polymer | | Injection | Yes | Yes | Yes | | Compatible endoscopy working channel | 2.8 mm or larger | 2.8 mm or larger | 2.8 mm or larger | | Compatible guidewire | Traditional guidewire (4.5m) or short guidewire (2.6m) with 0.021” ~ 0.035” diameter | Traditional guidewire (4.5m) or short guidewire (2.6m) with 0.021” ~ 0.035” diameter | Traditional guidewire (4.5m) or short guidewire (2.6m) with 0.021” ~ 0.035” diameter | | Energy Used | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | | Maximum Voltage Rating | 700 V peak (1400 V peak-to-peak) | 750 V peak (1500 V peak-to-peak) | 750 V peak (1500 V peak-to-peak) | | Insulation | Yes | Yes | No | | Packaging | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | | Shelf Life | 3 years | 3 years | 3 years | Page 4 of 7 {8} 510(k) Summary Taewoong Medical K260962 Page 5 of 7 | | Subject Device | Primary Predicate Device (K232162) | Secondary Predicate Device (K013153) | | --- | --- | --- | --- | | Sterilization method / SAL | EO Sterilization, SAL of 10^{-6} | EO Sterilization, SAL of 10^{-6} | EO Sterilization, SAL of 10^{-6} | | Biocompatibility | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 | | Electromagnetic compatibility and Electrical Safety | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 | Page 5 of 7 {9} 510(k) Summary Taewoong Medical K260962 Page 6 of 7 # 9. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING ## Biocompatibility Testing Biocompatibility testing was conducted to the following standards: - ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation - ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization - ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity - USP 43 <85>, Bacterial Endotoxin Testing - USP 43 <161>, Bacterial Endotoxin Testing ## Electrical Safety The subject device was tested against the following standard for electrical safety: - IEC 60601-1:2005/AMD1:2012/AMD2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ## Electromagnetic Compatibility (EMC) The subject device was tested against the following standards for electromagnetic compatibility: - IEC 60601-1-2:2014/AMD1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-2-2:2017/AMD1:2023, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories - IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment ## Software Not applicable as the subject device does not contain software. ## Performance Testing The following performance testing was conducted: - Visual inspection - Dimension - Tensile Strength {10} 510(k) Summary Taewoong Medical K260962 Page 7 of 7 - Leakage - Resistance - Packaging compatibility - Endoscopy compatibility - Device Operability - Cutting wire function - HF Dielectric Strength - Interconnection conditions for HF applications - Detachable connector retention - Rotation - Thermal performance ## 10. CONCLUSION The results of the performance testing described above demonstrate that the Sphincterotome performs equivalently as compared to the primary and secondary predicate devices and supports a determination of substantial equivalence. Page 7 of 7