← Product Code [FBK](/productcode/FBK) · K260262 # Injection Needle (K260262) _Mirco-Tech (Nanjing) Co., Ltd. · FBK · May 29, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260262 ## Device Facts - **Applicant:** Mirco-Tech (Nanjing) Co., Ltd. - **Product Code:** [FBK](/productcode/FBK.md) - **Decision Date:** May 29, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The injection needle is intended for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. ## Device Story Sterile, single-use endoscopic injection needle; used with endoscope to access GI tract. Device consists of needle, inner/outer tubes, protection tube, and handles. Operator extends needle through endoscope working channel to pierce target tissue; syringe connected to infusion handle delivers substances. Used in clinical settings by physicians. Benefits include targeted delivery of therapeutic agents or markers for GI procedures. No AI/ML or software components. ## Clinical Evidence No clinical data were necessary and submitted in this 510(k) submission. Bench testing included dimension, penetration force, Luer connector, operating performance, endoscope compatibility, flow, leakage, tensile strength, and particulate contamination tests. Biocompatibility evaluated per ISO 10993-1. Shelf-life validated per ASTM F1980. Sterilization validated per ISO 11135. ## Technological Characteristics Sterile, single-use endoscopic accessory. Components: needle, inner/outer tubes, protection tube, handles. EO sterilized (SAL 10^-6). Shelf life 3 years. Mechanical operation via manual handle control. Dimensions vary by model (e.g., 1.8 mm outer sheath, 2500 mm length, 3/8 mm needle lengths). ## Regulatory 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 - Injection Needle ([K150434](/device/K150434.md)) ## Reference Devices - Interject Injection Therapy Needle Catheter ([K171454](/device/K171454.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 29, 2026 Mirco-Tech (Nanjing) Co., Ltd. Sally He Regional RA Manager #10 Gaoke Third Rd. Nanjing National Hi-Tech, Industrial Development Zone Nanjing, Jiangsu 210032 China Re: K260262 Trade/Device Name: Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBK Dated: April 29, 2026 Received: April 29, 2026 Dear Sally He: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260262 - Sally He Page 2 (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-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). {2} K260262 - Sally He Page 3 Sincerely, SHANIL P. HAUGEN -S Shanil P. Haugen, Ph.D. 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. | K260262 | ? | | Please provide the device trade name(s). | | ? | | Injection Needle | | | | Please provide your Indications for Use below. | | ? | | The injection needle is intended for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI 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) | ? | {4} K260262 Page 1 of 2 510(k) #: K260262 510(k) Summary Prepared on: 2026-04-29 Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Mirco-Tech (Nanjing) Co., Ltd. | | --- | --- | | Applicant Address | No.10 Gaoke Third Rd Nanjing National Hi-Tech, Industrial Development Zone Nanjing Jiangsu 210032 China | | Applicant Contact Telephone | +86-25-58646378 | | Applicant Contact | Ms. Sally He | | Applicant Contact Email | ra.mtus@mtmed.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | Injection Needle | | --- | --- | | Common Name | Endoscope and accessories | | Classification Name | Endoscopic Injection Needle, Gastroenterology-Urology | | Regulation Number | 876.1500 | | Product Code(s) | FBK | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K150434 | Injection Needle | FBK | | K171454 (reference) | Interject Injection Therapy Needle Catheter (reference device only) | FBK | Device Description Summary 21 CFR 807.92(a)(4) The proposed device Injection Needle is a sterile, single-use endoscopic device, intended for use in conjunction with an endoscope to perform endoscopic injections in the GI tract. The Injection Needle is mainly composed of needle, inner tube, outer tube, protection tube, front handle and infusion handle. It reaches the target tissue of the human body through the endoscope's working channel, operate the handle to control the needle to extend, pierce the Injection Needle into the target tissue, and inject substances into it by connecting the syringe. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^(-6) and placed in a sterility maintenance package to ensure a shelf life of 3 years. Intended Use/Indications for Use 21 CFR 807.92(a)(5) The injection needle is intended for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. Indications for Use Comparison 21 CFR 807.92(a)(5) The indications for use of proposed device are identical to those of the predicate device (K150434). {5} K260262 Page 2 of 2 # Technological Comparison 21 CFR 807.92(a)(6) The proposed device incorporates the same principle of operation, packaging fundamental technology and sterilization as those featured in the predicate device cleared under K150434. The differences include a 1.8 mm outer sheath diameter, a 2500 mm working length for certain device models, 3mm and 8mm needle lengths for certain device models, component configuration of the device models, and manufacturing materials. The configuration and material of proposed device is similar to predicate device, although there are some differences, a reference device Interject Injection Therapy Needle Catheter (cleared under K171454) that has the same product code FBK, intended use and similar material is used to verify the tensile strength of the proposed device is adequate to ensure safety and effectiveness of the device during the endoscopic procedure. Therefore, those differences have been considered not to affect the substantially equivalency between the proposed and predicate device K150434 concerning the safety and effectiveness. # Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. The following tests are conducted: - Dimension Test - Penetration force Test; - Luer Connector Test; - Operating performance Test; - Endoscope compatibility performance Test; - Flow Test; - Leakage Test; - Tensile strength Test - Particulate contamination Test The biocompatibility evaluation was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process. Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Sterilization validation was carried out in accordance with ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices". No clinical data were necessary and submitted in this 510(k) submission. The results of the nonclinical tests mentioned demonstrated that the proposed device is as safe, as effective, and performs as well as the predicate device(K150434). --- **Source:** [https://fda.innolitics.com/device/K260262](https://fda.innolitics.com/device/K260262) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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