← Product Code [PIF](/productcode/PIF) · K260110 # danumed Extension Set for Gastrostomy Button (K260110) _Danumed Medizintechnik GmbH · PIF · Sep 10, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260110 ## Device Facts - **Applicant:** Danumed Medizintechnik GmbH - **Product Code:** [PIF](/productcode/PIF.md) - **Decision Date:** Sep 10, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use This enteral extension set may only be used for enteral feeding and/or to administer medications via the stomach. It may only be used on patients who have a low profile gastrostomy button (button) inserted. It serves to connect the button and feeding set or enteral syringes. The enteral extension set may only be used on one patient (single-patient product) and must be replaced after 14 days. ## Device Story Extension set for gastrostomy buttons; facilitates fluid/enteral nutrition transfer between gastrostomy button and enteral syringe or feeding set. Components include tubing, distal/proximal connectors (ENFit or Y-ENFit), and tube clamp. Used by patients or caregivers in home or clinical settings. Device connects to button, delivers nutrition/medication, then is disconnected, cleaned with warm water, and stored between uses. Single-patient use; 14-day replacement cycle. Benefits include reliable delivery of enteral nutrition and medication to patients with existing gastrostomy access. ## Clinical Evidence No clinical data. Bench testing performed per DIN EN ISO 20695:2020 (FDA recognition 9-138) including performance after cleaning, resistance to liquid leakage under pressure, strength of Tritan connector, resistance to tension, and flow rate. ## Technological Characteristics Consists of tubing, distal/proximal connectors (ENFit/Y-ENFit), and tube clamp. Features ENSwivel connector innovation. Materials are identical to predicate. Complies with ISO 20695:2020. Single-patient use, non-sterile (cleaned by user). ## Regulatory Identification A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use). ## Special Controls *Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. ## Predicate Devices - AQUARIUS™ Extension Feeding Set ([K141631](/device/K141631.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} **U.S. FOOD & DRUG** ADMINISTRATION September 10, 2026 Danumed Medizintechnik GmbH Helena Bastian Head of Quality and Regulatory Department Stadtamhof 18 Regensburg, 93059 Germany Re: K260110 Trade/Device Name: danumed Extension Set for Gastrostomy Button Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIF, KNT Dated: March 13, 2026 Received: August 11, 2026 Dear Helena Bastian: 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. {1} K260110 - Helena Bastian 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} K260110 - Helena Bastian 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, **STEPHANIE COLE -S** for 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. | K260110 | ? | | Please provide the device trade name(s). | | ? | | danumed Extension Set for Gastrostomy Button | | | | Please provide your Indications for Use below. | | ? | | This enteral extension set may only be used for enteral feeding and/or to administer medications via the stomach. It may only be used on patients who have a low profile gastrostomy button (button) inserted. It serves to connect the button and feeding set or enteral syringes. The enteral extension set may only be used on one patient (single-patient product) and must be replaced after 14 days. | | | | 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} K260110/S001 Page 1 of 2 | 510(k) #: K260110 | 510(k) Summary | Prepared on: 2026-08-12 | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | Applicant Name danumed Medizintechnik GmbH Applicant Address Stadtamhof 18 Regensburg 93059 Germany Applicant Contact Telephone 00499418905882 Applicant Contact Ms. Helena Bastian Applicant Contact Email hb@danumed.com Device Name 21 CFR 807.92(a)(2) Device Trade Name danumed Extension Set for Gastrostomy Button Common Name Gastrointestinal tube and accessories Classification Name Gastrointestinal Tubes With Enteral Specific Connectors Regulation Number 876.5980 Product Code(s) PIF, KNT Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K141631 AQUARIUS™ Extension Feeding Set KNT Device Description Summary 21 CFR 807.92(a)(4) The danumed Extension Set is an extension set, enteral tubing extension or safety connector that is used to transfer fluids and enteral nutrition between a gastrostomy button and an enteral syringe or enteral giving set. From the giving set, the enteral nutrition or fluid is passed via the extension set into the gastrostomy button and thus into the stomach of the artificially fed patient. The Extension Set is a single patient use product that is used by the patient up to a maximum of 14 days. After food administration the Extension Set is disconnected from the button and removed. It is cleaned of food residues with clear warm water after each use and put aside. Intended Use/Indications for Use 21 CFR 807.92(a)(5) This enteral extension set may only be used for enteral feeding and/or to administer medications via the stomach. It may only be used on patients who have a low profile gastrostomy button (button) inserted. It serves to connect the button and feeding set or enteral syringes. The enteral extension set may only be used on one patient (single-patient product) and must be replaced after 14 days. Indications for Use Comparison 21 CFR 807.92(a)(5) Although differing in wording, both indications for use statements contain the same statement that the product is an extension set for a Gastrostomy Button. Both devices are intended to be used as an extension set for gastric feeding devices to provide delivery of feeding media from nutrition reservoir into a patient feeding tube. Slightl differences in wording of the indications for use are not critical to the intended use of the device, the differences do not affect the safety and performance of the device when used as labeled. Technological Comparison 21 CFR 807.92(a)(6) {5} K260110/S001 Page 2 of 2 Overall technological characteristics are the same: The general design and composition of the devices are the same: Both extension sets consist of a tube, a distal and a proximal connector and a tube clamp. At the proximal end there is either a single ENFit connector or a Y-ENFit connector. Regarding the materials used for the devices, no difference can be stated. Nevertheless, there are three minor differences in the design of the proposed and the primary predicate device: 1. The ENFit connector(s) at the proximal end are slightly different, since the danumed Extension Sets come with the ENSwivel innovation. 2. For the danumed Extension Set is an additional tubing length of 5cm / 2in available. 3. There is a difference in the labeling on the subject device, as already mentioned above. However, these three aspects do not affect safety or effectiveness of the danumed Extension Set. These differences do not have effect on the patient and do not increase risks associated with the use of the device. Both the subject device's and the predicate device's properties have been successfully tested per applicable standards and based also relevant biocompatibility testing. The identified small differences will not raise new questions on the safety and effectiveness of the proposed device as evidence by the provided Substantial Equivalence Comparison. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Performance Bench Testing for the danumed Extension Set was conducted based on the requirements of DIN EN ISO 20695:2020 (corresponding to FDA recognized standard ISO 20695:2020, recognition number: 9-138). Following testing was carried out: - Performance after cleaning - Resistance to liquid leakage under pressure - Strength properties of the Tritan connector - Resistance to tension - flow rate Not Applicable No clinical testing is submitted. --- **Source:** [https://fda.innolitics.com/device/K260110](https://fda.innolitics.com/device/K260110) **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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