Durashield Device Kit

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 17, 2026 SurGenTec, LLC Richard Sharp Director of Engineering 911 Clint Moore Rd. Boca Raton, Florida 33487 Re: K252995 Trade/Device Name: Durashield Device Kit Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor For Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: August 18, 2026 Received: August 18, 2026 Dear Richard Sharp: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above 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- U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252995 - Richard Sharp Page 2 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-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, Sergio M. De Del Castillo -S for Jaime Raben, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2} | 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. | K252995 | ? | | Please provide the device trade name(s). | | ? | | Durashield™ Device Kit | | | | Please provide your Indications for Use below. | | ? | | The DuraShield™ Device Kit is indicated for use as a nerve and soft tissue protector during spinal surgery in the lumbar spine. Durashield is intended to provide shielding, guarding, and retraction of the dura, nerve roots, blood vessels, and other sensitive soft tissue structures to maintain a clear surgical field during open and minimally invasive spinal procedures. | | | | 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) | ? | {3} K252995, Page 1 of 2 ## 510(k) Summary | Device Trade Name: | DuraShield™ Device Kit | | --- | --- | | Manufacturer: | SurGenTec LLC. 911 Clint Moore Road Boca Raton, FL 33487 | | Contact: | Richard Sharp Jr. Director of Engineering | | Date Prepared: | September 14, 2026 | | Classifications: | Neurology, General & Plastic Surgery | | Class: | II | | Product Codes: | GZT | | Primary Predicate: | Geister retractor for neuro – and spine surgery (K180610) | ### Indications For Use: The DuraShield™ Device Kit is indicated for use as a nerve and soft tissue protector during spinal surgery in the lumbar spine. Durashield is intended to provide shielding, guarding, and retraction of the dura, nerve roots, blood vessels, and other sensitive soft tissue structures to maintain a clear surgical field during open and minimally invasive spinal procedures. ### Device Description: The DuraShield™ Device Kit is a sterile, single-use system designed to protect delicate soft tissue and nerve structures during spinal surgery. The kit includes specialized surgical instruments to provide shielding, guarding, and retraction. One or more shields may be utilized to anchor and resist movement of soft tissue and nerve tissue, helping maintain a clear surgical field throughout the procedure. The DuraShield™ Device Kit is suitable for use in both open and minimally invasive spinal surgeries. ### Predicate Device: SurGenTec LLC. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, DuraShield is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices: {4} K252995, Page 2 of 2 Primary Predicate: Geister retractor for neuro – and spine surgery (K180610) ### Performance Testing Summary: The following bench tests were evaluated to demonstrate substantial equivalence: - Sterilization Validation - Packaging Validation - Neurotoxicity Assessment - Hemolysis Assessment - Biocompatibility Testing - Tip Tensile Strength - Deployment Testing - Cannula Bend Testing - Cadaver Studies The results of the above testing demonstrate that the DuraShield Device Kit is substantially equivalent to the predicate devices and can perform as intended. ### Substantial Equivalence: The data presented within the subject 510(k) demonstrates that the DuraShield Device Kit is substantially equivalent to the predicate and reference devices. The subject, predicate, and reference devices have the same intended use, and are intended to be used during a surgical procedure to retract and protect soft tissue. The subject device has different technological characteristics (i.e., device design and materials) compared to the predicate and reference devices, however, the differences in design do not raise new questions of safety and effectiveness. The methods used to assess the subject device are acceptable and the results demonstrate substantial equivalence when used as intended. ### Conclusion: The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. DuraShield is as safe, as effective, and performs as well as, or better, than the predicate devices.