FDA 510(k)

Easydrip Pen Needle, Easydrip Plus Pen Needle

K-Number: K193422 · 2021-02-02

ApplicantSandstone Medical (Suzhou), Inc.

Decision Date2021-02-02

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Easydrip Pen Needle, Easydrip Plus Pen Needle is a medical device manufactured by Sandstone Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2021-02-02 under approval number K193422. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Easydrip Pen Needle, Easydrip Plus Pen Needle?

Easydrip Pen Needle, Easydrip Plus Pen Needle is a medical device that received FDA 510(k) clearance on 2021-02-02. It is manufactured by Sandstone Medical (Suzhou), Inc.. The 510(k) number is K193422.

When was Easydrip Pen Needle, Easydrip Plus Pen Needle approved by the FDA?

Easydrip Pen Needle, Easydrip Plus Pen Needle received FDA 510(k) clearance on 2021-02-02, under approval number K193422.

What company makes Easydrip Pen Needle, Easydrip Plus Pen Needle?

Easydrip Pen Needle, Easydrip Plus Pen Needle is manufactured by Sandstone Medical (Suzhou), Inc..

What is the FDA product code for Easydrip Pen Needle, Easydrip Plus Pen Needle?

The FDA product code for Easydrip Pen Needle, Easydrip Plus Pen Needle is FMI.

Other Devices by Sandstone Medical (Suzhou), Inc.

K210864Safety Pen Needle K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.