Sterile syringes for single use with/without needle

FDA 510(k) K211211 · Azur Medical Company, Inc.

Substantially Equivalent

510(k) numberK211211

Submission

Device name
Sterile syringes for single use with/without needle
Applicant
Azur Medical Company, Inc.
Richmond, VA, US
Received
April 23, 2021
Decision date
October 7, 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
FMF – Syringe, Piston
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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More from Instylla, Inc.

510(k)DeviceDecision
K231719Medical Surgical MaskFXX · Traditional 03/19/2024SE
K211210Sterile Auto-Disable Syringes with/without Needle for Single UseFMF · Traditional 01/27/2022SE
K211214Sterile Hypodermic Needles for Single UseFMI · Traditional 10/14/2021SE

Questions and answers

When was Sterile syringes for single use with/without needle cleared by the FDA?

Sterile syringes for single use with/without needle (K211211) received a 510(k) decision of Substantially Equivalent on October 7, 2021, 167 days after the submission was received.

What is the product code of K211211?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.