← Product Code [FPD](/productcode/FPD) · K963779 # RUSCH ENTERAL FEEDING TUBE (K963779) _Rusch, Inc. · FPD · May 23, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K963779 ## Device Facts - **Applicant:** Rusch, Inc. - **Product Code:** [FPD](/productcode/FPD.md) - **Decision Date:** May 23, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The device is intended for introduction into the naris (nostril) and is used in the introduction of various commercial and/or compounded enteral diets to appropriate sites along the alimentary tract of the patient. ## Device Story Rusch Enteral Feeding Tube is a thermoplastic or elastomer tube, weighted or unweighted, designed for enteral nutrition delivery. Device features a distal outlet (spherical or polished open tip) and side perforations for diet dispersion; optional stainless steel stylet aids placement. Inserted through naris into alimentary tract. Used by clinicians to deliver commercial or compounded enteral diets. Provides direct nutritional support to patients unable to ingest food orally. Simple mechanical device; no electronic or software components. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Thermoplastic or elastomer tubing; 6 to 20 FR diameter; 6 to 72 inch length. Includes optional stainless steel stylet. Mechanical device; no energy source or software. ## 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 - Entech Enteral Feeding Tube ## 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} 1965+79 MAY 23 1997 1of2 F1 # Substantial Equivalence 510(k)Summary ## Rusch Inc. Enteral Feeding Tube To: Whom it may concern Date: 9/16/96 Submitter/ Contact - Name and Address Ronald J. Young Quality Manager Rusch Inc. 2450 Meadowbrook Parkway Duluth, GA 30136 Telephone: (770) 623-0816 Fax: (770) 623-1829 ## Device Details: Trade Name: Rusch Enteral Feeding Tube Common Name: Feeding Tube Classification Name: Tube - Feeding Predicate Legally Marketed Device: Entech Enteral Feeding Tube Page 1 of 2 {1} K963779 F2 2 of 2 ## Description of Device The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement ## Device Intended Use The device is intended for introduction into the naris (nostril) and is used in the introduction of various commercial and/or compounded enteral diets to appropriate sites along the alimentary tract of the patient. ## Technological Characteristics of the Device The device is equivalent is design and construction to the Entech Enteral Feeding Tube. It comes in a range of sizes from 6 to 20FR and from 6” to 72” in length. Page 2 of 2 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service MAY 23 1997 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Ronald J. Young Quality Manager Rusch, Inc. 2450 Meadowbrook Parkway Duluth, Georgia 30136 Re: K963779 Rusch Enteral Feeding Tube Dated: February 24, 1997 Received: February 27, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 FPD Dear Mr. Young: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} Sep. 30, 1996 10:10 FDA-ODE-DRAERD From: QUALITY ASSURANCE K 963779 Page 1 of 1 510(k) Number (if known): K963779 Device Name: Rusch Enteral Feeding Tube Indications For Use: The Device is intended for introduction into the Naris (Nostril) and is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient. Signed: [Handwritten signature] Title: Quality Manager Date: 9/30/96 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert R. Lathing (Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 510(k) Number K963779 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/device/K963779](https://fda.innolitics.com/device/K963779) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com