Needle Catheter Jejunostomy Repair Kit
by Biosearch Medical Products, Inc.
510(k) K840936
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840936 | Date22 Mar 1984 | 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- Withdrawn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 Needle Catheter Jejunostomy Repair Kit is a medical device designed for the repair of jejunostomy catheters, which are used to provide enteral nutrition or drainage through a surgically created stoma in the jejunum. This kit includes components necessary to re-establish or maintain patency of the catheter, ensuring continued access for therapeutic purposes. It falls under the product code KNT and is classified as a substantially equivalent device under FDA 510(k) regulations. The device is intended for clinical use in gastroenterology and urology settings, as reviewed by the respective advisory committees.
The kit is supplied as a sterile, single-use device, intended for use in controlled clinical environments such as hospitals or outpatient care facilities. It is regulated under the FDA’s 510(k) clearance process, with the original submission dated March 5, 1984, and classified under the Gastroenterology, Urology (GU) advisory committee. No additional regulatory status beyond the stated FDA 510(k) clearance is implied. The device is packaged and stored according to standard medical device sterilization protocols to ensure safety and efficacy upon use.
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Questions
AI-generated answers, 1 Oct 2026
What is the Needle Catheter Jejunostomy Repair Kit used for?
This kit is designed specifically for repairing jejunostomy catheters, which are tubes inserted surgically into the jejunum to deliver enteral nutrition or manage drainage. It includes components to re-establish or maintain catheter patency, ensuring reliable access for therapeutic purposes in gastroenterology and urology procedures.
Is the Needle Catheter Jejunostomy Repair Kit sterile and single-use?
Yes, the kit is supplied as a sterile, single-use device. Sterility is maintained through standard medical device sterilization protocols during packaging, ensuring safety and efficacy for one-time clinical use in controlled environments like hospitals or outpatient facilities.
How is the kit regulated and approved?
The kit is regulated under the FDA’s 510(k) clearance process, classified as substantially equivalent to prior devices. It was originally submitted on March 5, 1984, and reviewed by the Gastroenterology, Urology (GU) advisory committee, receiving clearance on March 22, 1984. The product code assigned is KNT.
Where can this kit be used?
The kit is intended for use in clinical settings where enteral nutrition or drainage management is performed, such as hospitals or outpatient care facilities. Its design ensures compatibility with standard procedures in gastroenterology and urology, where jejunostomy catheters are commonly utilized.
What storage and handling precautions should be followed?
The kit should be stored according to standard medical device protocols to preserve sterility. This includes keeping it in its original, unopened packaging, away from direct sunlight, extreme temperatures, and contamination. Always follow manufacturer guidelines for proper handling to maintain device integrity before use.