MINT MONO Sutures

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 Hans Biomed Corporation % Sarah Fitzgerald Senior Consultant Emergo by UL 2500 Bee Caves Rd. Bldg. 1, Suite 300 Austin, Texas 78746 Re: K254238 Trade/Device Name: MINT MONO Sutures Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: August 14, 2026 Received: August 14, 2026 Dear Sarah Fitzgerald: 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} K254238 - Sarah Fitzgerald 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} K254238 - Sarah Fitzgerald 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, TEK N. LAMICHHANE -S Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K254238 Device Name MINT MONO Sutures Indications for Use (Describe) MINT MONO Sutures are comprised of PDO and are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate. The suture is not intended for lifting or filling aesthetic uses. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K254238 # 510(k) Summary -K254238 ## MINT® MONO Sutures ### 1. Submission Sponsor Hans Biomed Corporation 64, Yuseong-Daero 1628 Beon-Gil Yuseong-Gu, Daejeon 34054 Korea Contact: Mark Bae Title: Regulatory Affairs Deputy Manager Telephone: 82-02-466-2266 Email: mhbae@hansbiomed.com ### 2. Submission Correspondent Emergo by UL 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.US.EmergoFDASubmissions@ul.com Contact: Sarah Marie Fitzgerald Title: Senior Consultant ### 3. Date Prepared September 18, 2026 ### 4. Device Identification Trade/Proprietary Name: MINT MONO Sutures Common/Usual and Classification Name: Polydioxanone absorbable surgical suture Regulation Number(s): 878.4840 Product Code(s): NEW Class: Class II Classification Panel: General & Plastic Surgery ### 5. Legally Marketed Predicate Device Device name: DemeDIOX Absorbable Surgical Suture 510(k) number: K181582 Manufacturer: Demetech Corporation Page 1 of 4 {5} K254238 # 6. Device Description MINT® Product Family Sutures, including MINT® MONO Sutures, are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. They are available in a range of lengths and thicknesses. They are provided sterile. They degrade and resorb over time. MINT® MONO Sutures are smooth sutures. MINT® MONO Sutures are part of the MINT® Product Family of Sutures. # 7. Indication for Use Statement MINT® MONO Sutures are comprised of PDO and are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate. The suture is not intended for lifting or filling aesthetic uses. # 8. Substantial Equivalence Discussion MINT® MONO Sutures are equivalent to DemeDIOX Absorbable Surgical Sutures cleared in K181582. MINT® Sutures (K220549) and PDREX Sutures (K173779) are provided as reference devices. The following table compares the MINT® MONO Sutures to the predicate device and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. Comparison of Characteristics | Attribute | Subject MINT® MONO Sutures | Predicate DemeDIOX Sutures K181582 | Comparison | | --- | --- | --- | --- | | Product Code / Regulation | NEW / 878.4840 | NEW / 878.4840 | Same | | Intended Use | Absorbable surgical sutures for use in soft tissue | Absorbable surgical sutures for use in soft tissue | Same | | Indications for Use | MINT® MONO Sutures are comprised of PDO and are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate. The suture is not intended for lifting or filling aesthetic uses. | DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable sutures with extended | Similar Provides fewer details compared to predicate but equivalent details compared to reference devices. | Page 2 of 4 {6} K254238 | Attribute | Subject MINT® MONO Sutures | Predicate DemeDIOX Sutures K181582 | Comparison | | --- | --- | --- | --- | | | | wound support (up to six weeks) is desirable. | | | Suture Material | Polydioxanone | Polydioxanone | Same | | Suture Characteristics | Synthetic absorbable monofilament | Synthetic absorbable monofilament | Same | | Sterilization | Ethylene oxide | Ethylene oxide | Same | | Size (USP) | Compliant with USP Standard Suture Sizes | Compliant with USP Standard Suture Sizes | Same | | Contact Type | Implant, Absorbable | Implant, Absorbable | Same | | Contact Duration | >30 days | >30 days | Same | | Suture Diameter | 7-0, 6-0, and 5-0 USP sizes | 6-0 USP size | Similar Within range of reference devices. | | Suture Tensile Strength | Compliant with USP <881> requirements | Compliant with USP <881> requirements except smallest is too short to perform knot pull test | Same | | Accessories | Needle / Cannula | Needle / Cannula | Same | | Accessory Material (Patient Contacting) | Stainless Steel (SUS 304) | Stainless Steel | Same | This submission is to add MINT® MONO Sutures, which are smooth, to cleared sutures in the MINT® Product Family of Sutures. All previously cleared MINT® Sutures are barbed. ### 9. Non-Clinical Performance Data Testing was conducted in alignment with the FDA guidance “Class II Special Controls Guidance Document: Surgical Sutures,” confirming that the design output meets the design input and specifications for the sutures. Testing conducted included biocompatibility evaluation and testing per ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-23, sterilization validation in accordance with ISO 11135-1, shelf-life testing in accordance with ASTM F88/F88M and ASTM F1929, tensile strength testing to confirm USP <881> monograph strength, dimension verification (length, diameter / gauge), degradation profile / degradation, residual tensile strength, cannula elasticity, cannula bending strength, and cannula pull-out testing. The results of non-clinical performance testing demonstrates substantial equivalence between the subject and predicate device. ### 10. Animal Performance Data No animal testing was conducted for this submission. Page 3 of 4 {7} K254238 # 11. Clinical Performance Data No clinical data was necessary to determine the substantial equivalence of this device. # 12. Statement of Substantial Equivalence All testing and evidence confirms that the subject device does not raise any new questions related to the safety or effectiveness and that the device is at least as safe and at least as effective as the predicate device for the intended use and indications for use. Therefore, the device can be considered substantially equivalent to the predicate device. Page 4 of 4