Replacement Silicone Gastrostomy Tube Kit #87600
by Superior Healthcare Group, Inc.
510(k) K880201
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880201 | Date14 Apr 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Replacement Silicone Gastrostomy Tube Kit #87600 is a medical device classified as a gastrostomy tube designed for enteral feeding and drainage. It consists of a silicone tube intended for percutaneous endoscopic gastrostomy (PEG) replacement, providing a secure pathway for the administration of nutrition, medications, or gastric decompression. The silicone material ensures durability and biocompatibility, reducing the risk of irritation or allergic reactions. This kit is intended for use in patients requiring long-term enteral access when a new gastrostomy tube is needed after the removal of an existing one.
This kit is supplied sterile and intended for single-use, ensuring patient safety and minimizing infection risk. It is intended for use in clinical settings such as hospitals, outpatient clinics, or home healthcare environments where gastrostomy management is performed. The device adheres to FDA regulatory standards, having received FDA 510(k) clearance under K880201, with a decision classification of Substantially Equivalent to a predicate device. The kit includes a silicone tube with a specified size (#87600) and may incorporate features such as secure attachment mechanisms for feeding administration sets. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Superior Healthcare Group, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Replacement Silicone Gastrostomy Tube Kit #87600 used for?
This kit is designed for percutaneous endoscopic gastrostomy (PEG) replacement, providing a secure pathway for enteral feeding, medication administration, or gastric decompression in patients requiring long-term enteral access. It replaces an existing gastrostomy tube when necessary, ensuring continued safe and effective nutritional support.
How is the Replacement Silicone Gastrostomy Tube Kit #87600 supplied?
The kit is supplied sterile and intended for single-use only. This ensures patient safety by minimizing the risk of infection and maintains the integrity of the device for one-time clinical use.
Is the silicone tube in this kit reusable?
No, the silicone tube in this kit is explicitly intended for single-use. Reusing medical devices like this can compromise sterility, increase infection risks, and may damage the tube’s structural integrity, which is why it is designed for one-time clinical application.
What size is the silicone tube in this kit, and does it include additional features?
The silicone tube in this kit is designated as size #87600. While the exact specifications of additional features (such as attachment mechanisms for feeding administration sets) are not detailed, the kit is designed to provide secure and reliable enteral access, ensuring compatibility with standard clinical practices.
How should the Replacement Silicone Gastrostomy Tube Kit #87600 be stored?
Storage should follow the manufacturer’s guidelines to preserve sterility and functionality. Typically, this involves keeping the kit in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until ready for use.