← Back to catalogue

Nipro Disposable Syringes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030683

by Nipro Medical Corp.

Identifiers

510(k) Number
K030683 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Nipro Disposable Syringes are single-use medical devices designed for the precise measurement and administration of fluids, including medications and contrast agents. They feature a polypropylene barrel and a specially formulated elastomer stopper to ensure smooth, accurate plunger movement throughout the barrel's length. The syringes are available in 2- or 3-part constructions, with or without attached needles, and include options for fixed insulin needles and various luer tip configurations.

These syringes are supplied sterile for clinical use in hospital and home care settings, intended for single use and disposal after administration. The devices are manufactured by Nipro Medical Corp. and are authorized under FDA 510(k) number K030683, classified under product code FMF. They are stored in a dry environment and are designed to meet general hospital equipment standards for safety and performance.

Frequently asked questions

What are Nipro Disposable Syringes used for?

These syringes are designed for the precise measurement and administration of fluids, including medications and contrast agents. They are intended for clinical use in hospital and home care settings, ensuring accurate dosing and smooth plunger movement throughout the barrel's length.

How are these syringes supplied?

They are supplied sterile for immediate clinical use. The sterile packaging ensures they are ready for use in medical procedures without the need for additional sterilization, supporting infection control protocols in both hospital and home care environments.

Are they single-use or reusable?

They are strictly single-use devices. After administration, they must be disposed of appropriately to prevent reuse, ensuring patient safety and maintaining the integrity of the sterile, precision-engineered components.

What sizes and configurations are available?

The syringes are available in 2- or 3-part constructions. They can be ordered with or without attached needles, and include options for fixed insulin needles and various luer tip configurations to suit different clinical needs.

How should they be stored?

They should be stored in a dry environment. Proper storage helps maintain the integrity of the packaging and the sterility of the device until its intended use.

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: SYRINGE - Nipro, Nipro Disposable Syringes with Needle - Medline, Homepage | Nipro, Nipro Disposable Syringe - 3 cc - pattersonvet.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nipro Medical Corp.

Sources (1)

  • FDA 510(k) K030683 24 fields · synced Sep 25, 2026