← Product Code [KNT](/productcode/KNT) · K960677 # KANGAROO JEJUNAL FEEDING SYSTEM (K960677) _Sherwood Medical Co. · KNT · May 13, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K960677 ## Device Facts - **Applicant:** Sherwood Medical Co. - **Product Code:** [KNT](/productcode/KNT.md) - **Decision Date:** May 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The intended uses and components of the Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System. ## Device Story System comprises gastrostomy tube and jejunal feeding tube; gastrostomy tube is dual-lumen Foley-type catheter with retention balloon and outlet port; jejunal tube inserted through gastrostomy tube to provide jejunal access; used in clinical settings for enteral feeding; provides enteral nutrition delivery; manufactured from polyether-based polyurethane; ethylene oxide sterilized. ## Clinical Evidence No clinical data; substantial equivalence based on identical design, materials, and intended use to predicate devices. ## Technological Characteristics Dual-lumen Foley-type gastrostomy catheter; polyether-based polyurethane jejunal tube; 6-12 French diameters; 18-36 inch lengths; ethylene oxide sterilization (SAL 10^-6). ## 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 - BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube ([K900590](/device/K900590.md)) - BioSearch Dobbhoff GastroTrac Jejunal Feeding System ([K900624](/device/K900624.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} K960677 THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990. SECTION 6 - 510K SUMMARY Submitted By: Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, (314) 241-5700 Contact: C. Winters-Heard, RAC, Regulatory Affairs Manager The Kangaroo® EntriStar Jejunal Feeding System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distributed by Sherwood Medical. Sherwood Medical Company will manufacture this product line. The intended uses and components of the Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System. The Kangaroo Jejunal Feeding System is comprised of a gastrostomy tube and a jejunal feeding tube. The gastrostomy tube is identical to the BioSearch gastrostomy tube, and is a Foley-type of catheter. It is a dual lumen catheter with a retention balloon and outlet port at the distal end. The proximal end has a female luer balloon inflation valve and an outlet adapter. The Gastrostomy Tube allows access to the jejunum by the Kangaroo Jejunal Feeding Tube. It is ethylene oxide sterilized to an SAL of 10⁶. The Jejunal feeding tube is included with the system, and may also be packaged and sold separately. It consists of a polyether-based polyurethane and will be available in lengths ranging from 18" to 36", and in a range of tube diameters from 6 to 12 French. Technological and performance characteristics of the Kangaroo Jejunal Feeding System are the same as that of the Biosearch predicate device; only the manufacturing site has been changed. Page 9 of 10 February 15, 1996 y --- **Source:** [https://fda.innolitics.com/device/K960677](https://fda.innolitics.com/device/K960677) **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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