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Nipro Safe Touch Huber Infusion Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113470

by Nipro Medical Corporation

Identifiers

510(k) Number
K113470 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)

The Nipro Safe Touch Huber Infusion Set is a non-coring Huber needle infusion set designed for the infusion of drug solutions into or blood sampling from an implanted reservoir. It features an integrated safety device that is activated during use to provide enhanced safety without requiring a change in needle puncturing technique.

This device is supplied as a single-use infusion set. It has received FDA 510(k) clearance for clinical use in general hospital settings.

Frequently asked questions

What is the primary purpose of the Nipro Safe Touch Huber Infusion Set?

This device is a non-coring Huber needle designed specifically for the infusion of drug solutions into or blood sampling from an implanted reservoir in a clinical setting.

Is the Nipro Safe Touch Huber Infusion Set intended for multiple uses?

No, this device is supplied as a single-use infusion set. It should be disposed of after a single procedure to maintain sterility and patient safety.

Does the safety mechanism require a change in clinical technique?

No, the integrated safety device is designed to be activated during use without requiring the clinician to change their standard needle puncturing technique.

What is the regulatory status of this infusion set?

The Nipro Safe Touch Huber Infusion Set has received FDA 510(k) clearance for clinical use in general hospital settings, as indicated by the K113470 submission.

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: Safetouch Huber needle set | Nipro safetouch huber needle infusion set, PDF 510(k) Summary NIPRO SafeTouch Huber Infusion Set, NIPRO SAFE TOUCH HUBER INFUSION SET - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (1)

  • FDA 510(k) K113470 24 fields · synced Sep 24, 2026