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Needle & Blade Counter & Disposal Unit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872313

by Gary Plastic Packaging Corp.

Identifiers

510(k) Number
K872313 FDA 510(k)
FDA Product Code
MMK 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)

This device is a Container, Sharps, designed to safely collect, count, and dispose of used needles and blades. It provides a secure method for healthcare professionals to manage sharps waste while maintaining occupational safety and preventing needlestick injuries.

The Needle and Blade Counter and Disposal Unit is intended for single-use in clinical settings such as general hospitals. It is classified as a Class II device under FDA regulation 880.5570 and has received FDA 510(k) clearance (K872313) as substantially equivalent to a predicate device. The unit is non-sterile and reusable for disposal purposes, with multiple reference codes (e.g., MMK) for inventory tracking.

Frequently asked questions

What is the primary purpose of this device in a clinical setting?

This device is designed to safely collect, count, and dispose of used needles and blades in clinical settings like general hospitals. It helps healthcare professionals manage sharps waste securely while reducing the risk of needlestick injuries and ensuring occupational safety.

Is this device intended for single-use or can it be reused?

The device itself is reusable for disposal purposes, but it is intended for single-use in terms of collecting and counting needles and blades. After use, it can be reused to safely dispose of additional sharps waste, making it a durable solution for clinical settings.

How is the device tracked or inventoried in a healthcare facility?

The device includes multiple reference codes (e.g., MMK) and registration numbers for inventory tracking. These identifiers help healthcare facilities manage stock levels, monitor usage, and ensure compliance with waste disposal protocols.

What type of sterility does this device have, and how should it be stored?

The device is non-sterile, meaning it is not intended for direct patient contact or sterile procedures. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its structural integrity and functionality.

What regulatory pathway was followed for FDA clearance, and what does that mean for buyers?

The device received FDA 510(k) clearance (K872313) under a Traditional Review pathway, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device (regulated under 21 CFR 880.5570) and is approved for use in general hospital settings.

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 & BLADE COUNTER & DISPOSAL UNIT - Innolitics, NEEDLE & BLADE COUNTER & DISPOSAL UNIT 510(k) K872313 - fda.report, GARY PLASTIC PACKAGING CORP. FDA Filings - FDA.report, Gary Plastic Packagin… — 1 FDA 510 (k) · DeviceClearance, Needle Engine — Ship 3D to the web from Unity, Blender, or code

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gary Plastic Packaging Corp.

Sources (1)

  • FDA 510(k) K872313 24 fields · synced Sep 19, 2026