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Needle Catheter Jejunostomy Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K822565

by Bio-Research Associates, Inc.

Identifiers

510(k) Number
K822565 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Needle Catheter Jejunostomy Kit is a device used for jejunostomy procedures, involving the placement of a catheter into the jejunum for nutritional support or drainage. It is classified under product code KNT and was evaluated by the Gastroenterology and Urology advisory committee during its regulatory review.

The device received traditional 510(k) clearance (K822565) from Bio-Research Associates, Inc. on September 28, 1982, and was found substantially equivalent to a predicate device. It is manufactured in McHenry, Illinois, and is authorized for distribution in the United States.

Frequently asked questions

What is the Needle Catheter Jejunostomy Kit used for?

The Needle Catheter Jejunostomy Kit is used for jejunostomy procedures, involving the placement of a catheter into the jejunum to provide nutritional support or drainage, as stated in the device description.

What regulatory pathway was used for the Needle Catheter Jejunostomy Kit?

The device received traditional 510(k) clearance, as indicated by the clearance_type field and the K-number K822565, showing it was found substantially equivalent to a predicate device.

Who manufactures the Needle Catheter Jejunostomy Kit and where is it made?

The Needle Catheter Jejunostomy Kit is manufactured by Bio-Research Associates, Inc. in McHenry, Illinois, United States, as shown in the address and applicant fields.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEEDLE CATHETER JEJUNOSTOMY KIT (K822565) — FDA 510 (k) | Innolitics, NEEDLE CATHETER JEJUNOSTOMY KIT 510 (k) K822565 - FDA.report, Bio-Research Associates, Inc. FDA 510(k) Products (1982-2013), NEEDLE CATHETER JEJUNOSTOMY KIT 510 (k) K830119 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Research Associates, Inc.

Sources (1)

  • FDA 510(k) K822565 24 fields · synced Sep 21, 2026