Identifiers
- 510(k) Number
- K943897 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
NU-SITE is a device classified under product code FPA, which corresponds to a connector, intravenous. It received FDA 510(k) clearance K943897 on February 10, 1995, and was found substantially equivalent to a predicate device.
The device was manufactured by Medex, Inc. located in Hilliard, Ohio. It is supplied as a non-sterile, single-use or reusable connector for intravenous applications, with no MRI safety information provided in the data. Storage and handling should follow standard practices for medical devices of this type.
Frequently asked questions
What is the NU-SITE device used for?
The NU-SITE is a connector designed for intravenous applications, classified under product code FPA as an intravenous connector, intended for use in general hospital settings to connect IV components.
Is the NU-SITE device sterile or non-sterile when supplied?
The NU-SITE is supplied as a non-sterile device, meaning it requires sterilization by the user before use if sterility is required for the intended application.
Can the NU-SITE connector be reused or is it single-use only?
The NU-SITE is designed for either single-use or reusable applications, allowing flexibility based on clinical protocols and institutional policies for intravenous connector reuse.
What regulatory pathway was used for the NU-SITE device clearance?
The NU-SITE received FDA 510(k) clearance under submission K943897, determined to be substantially equivalent to a predicate device, and was cleared via the traditional 510(k) pathway on February 10, 1995.
Who manufactures the NU-SITE and where is it located?
The NU-SITE is manufactured by Medex, Inc., located at 3637 Lacon Rd., Hilliard, Ohio, 43026, United States, as listed in the device authorization records.
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: NU-SITE (K943897) — FDA 510 (k) | Innolitics, NU-SITE 510(k) K943897 - FDA.report, NU-SITE - (CONNECTOR,INTRAVENO by MEDEX INC. - 56360) - ArmyProperty.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943897 | Class II | Active |
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Manufacturer
- Manufacturer
- Medex, Inc.
Sources (1)
- FDA 510(k) K943897 24 fields · synced Sep 25, 2026