← Back to catalogue

Medisystems Anti-Stick Injection Site Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910733

by Medisystems Corp.

Identifiers

510(k) Number
K910733 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medisystems Anti-Stick Injection Site Needle is a hypodermic needle designed to reduce accidental needlesticks during injections. Its anti-stick surface minimizes adhesion of tissue, facilitating safer handling and disposal while maintaining functionality for subcutaneous or intramuscular administration.

This single-use, plastic needle is intended for use in general hospital settings and complies with OSHA’s engineered sharps protection requirements. Supplied sterile in a packaged format, it is regulated under FDA 510(k) clearance (K910733) and classified under product code FMI. Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What makes this needle safer to handle compared to standard hypodermic needles, and how does it reduce accidental needlesticks?

The Medisystems Anti-Stick Injection Site Needle features an anti-stick surface that prevents tissue from adhering to the needle during use. This design significantly reduces the risk of accidental needlesticks when handling or disposing of the needle, as the tissue does not cling to the surface like it might with conventional needles. It maintains the same functionality for subcutaneous or intramuscular injections while improving safety.

Is this needle intended for reuse, or is it meant to be used only once? How does that affect its safety?

This needle is explicitly designed for single-use only. Its anti-stick surface and sterile packaging are optimized for one-time administration, which minimizes contamination risks and ensures patient safety. Reuse is not recommended, as it could compromise sterility and increase infection risks.

What storage conditions should be followed for this needle to maintain sterility and functionality?

Like all sterile medical devices, the Medisystems Anti-Stick Injection Site Needle should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow standard sterile medical device protocols—avoid exposure to moisture, chemicals, or physical damage to preserve sterility and performance.

Does this needle comply with workplace safety regulations like OSHA’s engineered sharps protection requirements?

Yes, this needle is explicitly designed to comply with OSHA’s engineered sharps protection requirements. Its anti-stick surface reduces the likelihood of accidental needlesticks during handling or disposal, aligning with workplace safety standards for sharps in general hospital settings.

How is this needle supplied, and what should clinicians expect when unpacking it?

The needle is supplied sterile and pre-packaged in a format designed for single-use. Clinicians should expect a sealed, sterile barrier that protects the needle until use. The packaging ensures sterility is maintained until the needle is ready for administration, requiring no additional preparation beyond standard sterile technique.

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: Medisystems Anti-stick Injection Site Needle, PDF Medic Plastic Anti-Stick Needle/Connector - Henry Schein, MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE 510 (k)… - FDA.report, Medisystems Medic Plastic Needles - Medline, MEDISYSTEMS CORPORATION M8-5007 Medisystems Medic Anti-stick Needle ...

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
Medisystems Corp.

Sources (1)

  • FDA 510(k) K910733 24 fields · synced Sep 19, 2026