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K Number
K992626
Device Name
SURE-WAY REUSABLE SHARPS CONTAINER
Manufacturer
SURE-WAY SYSTEMS, INC.
Date Cleared
1999-12-16

(133 days)

Product Code
FMI
Regulation Number
880.5570
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sure-Way Reusable Container is intended to be used for the disposal of contaminated medical sharps in health care facilities.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Sure-Way Reusable Sharps Container." It does not contain information on acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot answer your request based on the provided text. The document is primarily focused on the regulatory approval of the device and its intended use, not on performance studies or their results.

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).