Sterile Hypodermic Needles for Single Use

FDA 510(k) K211214 · Azur Medical Company, Inc.

Substantially Equivalent

510(k) numberK211214

Submission

Device name
Sterile Hypodermic Needles for Single Use
Applicant
Azur Medical Company, Inc.
Richmond, VA, US
Received
April 23, 2021
Decision date
October 14, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FMI – Needle, Hypodermic, Single Lumen
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5570
Specialty
General Hospital

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More from Ningbo Medsun Medical Co., Ltd.

510(k)DeviceDecision
K231719Medical Surgical MaskFXX · Traditional 03/19/2024SE
K211210Sterile Auto-Disable Syringes with/without Needle for Single UseFMF · Traditional 01/27/2022SE
K211211Sterile syringes for single use with/without needleFMF · Traditional 10/07/2021SE

Questions and answers

When was Sterile Hypodermic Needles for Single Use cleared by the FDA?

Sterile Hypodermic Needles for Single Use (K211214) received a 510(k) decision of Substantially Equivalent on October 14, 2021, 174 days after the submission was received.

What is the product code of K211214?

The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.