Who is the manufacturer of KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT?

Sherwood Medical Co. filed the 510(k) submission for KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (K954429).

What is the FDA product code for KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT?

KNT. It is classified under 21 CFR 876.5980 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT?

Low-Profile Gastrostomy Device (K923474).

Who can help prepare an FDA 510(k) submission like KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT

K954429 · Sherwood Medical Co. · KNT · Mar 8, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K954429
Device Name	KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
Applicant	Sherwood Medical Co.
Product Code	KNT · Gastroenterology, Urology
Decision Date	Mar 8, 1996
Decision	SESK
Submission Type	Traditional
Regulation	21 CFR 876.5980
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as a conduit for insertion of enteral access devices such as gastric decompression catheters or intestinally placed feeding catheters.

Device Story

Sterile, single-use gastrostomy feeding kit; includes low-profile gastrostomy tube, obturator, and insertion/removal accessories. Tube placed through existing abdominal stoma into stomach; provides conduit for enteral nutrition formula delivery or gastric decompression. Obturator mechanically elongates internal retention device to reduce diameter during insertion/removal, minimizing stoma trauma. Fixed-length tube design; includes optional step-up shims for customized fit against abdominal wall. Distal tip and internal retention device feature lubricious Hydromer coating to reduce insertion force. Used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. Device requires biocompatibility testing per ISO 10993 (Implantation, Cytotoxicity, Sensitization, Genotoxicity, Chronic Toxicity) and functional specification testing to ensure safety and efficacy.

Technological Characteristics

Materials: Gastrostomy tube with lubricious Hydromer coating. Design: Low-profile, fixed-length tube with internal retention device and obturator. Biocompatibility: ISO 10993 compliant. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring enteral nutrition or gastric decompression via an existing stoma.

Regulatory Classification

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

Low-Profile Gastrostomy Device (K923474)

Related Devices

K973891 — LAPAROSCOPIC GASTROSTOMY KIT · Applied Medical Resources · Jan 12, 1998
K130611 — ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE · Xeridiem Medical Devices · Dec 19, 2013
K122653 — MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES · Kimberly-Clark Corporation · Jun 26, 2013
K071191 — NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT · Novartis Nutrition Corp. · Jul 23, 2007
K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit · Degania Silicone , Ltd. · Mar 20, 2026

Submission Summary (Full Text)

{0} MAY - 8 1995 K954429 510(k) Summary of Safety & Efficacy: Kangaroo® EntriStar™ Skin-Level Gastrostomy Feeding Kit Submitted by: Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, (314) 621-7788 Contact: Dennis Pozzo, Regulatory Affairs Manager Date Prepared: September 11, 1995 The Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile gastrostomy tube. The Kangaroo® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT. The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as a conduit for insertion of enteral access devices such as gastric decompression catheters or intestinally placed feeding catheters. The stoma tube is designed so that it is a fixed length to correspond to the depth of the stoma. However, a "step-up shim" may be placed between the external retention device and the abdominal wall to customize the fit to the patient. The Skin-Level Gastrostomy Tube is inserted and removed by inserting the obturator through the inner lumen of the stoma tube. When inserted, the obturator mechanically slenderizes (elongates) the internal retention device, which reduces its diameter to reduce the physical trauma to the stoma inherent in the insertion and removal procedures. The Skin-Level Gastrostomy Tube is available in various lengths designed to precisely fit the depth of the patient's stoma, which results in a snug fit between the surface of the external retention device and the patient's abdomen. An insertion/removal accessory is included for use when inserting and removing the gastrostomy tube. The distal tip of the obturator and the internal retention device are covered in lubricious Hydromer coating to reduce the force needed to insert the obturator and gastrostomy tube. Hydromer coating is currently used in several nasogastric feeding tubes marketed by Sherwood and Biosearch Medical Products which were cleared via the 510(k) process. In accordance with ISO 10993 Part-1 Biocompatibility Guidance, the Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is categorized as an implantable device, of permanent contact, contacting tissue/bone. Based on this classification, the kit will be required to pass the following battery of tests: Implantation (7 day), Cytotoxicity, Sensitization, Genotoxicity and Chronic Toxicity prior to the release of product for sale. In addition to biocompatibility testing, Sherwood has established functional specifications to ensure the device is safe and effective for its intended use. Sherwood believes that the Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is substantially equivalent to the Low-Profile Gastrostomy Device [Biosearch Medical Products, Somerville, NJ] which was cleared as 510K No. K923474. In fact, the device covered by this submission is simply a modified version of the design disclosed in K923474. Both kits utilize the same basic gastrostomy tube design and accessories.