FDA 510(k)

DROPLET PEN NEEDLE

K-Number: K171982 · 2018-03-21

Decision Date2018-03-21

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DROPLET PEN NEEDLE is a medical device manufactured by Htl-Strefa S.A. It received FDA 510(k) clearance on 2018-03-21 under approval number K171982. 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 DROPLET PEN NEEDLE?

DROPLET PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Htl-Strefa S.A. The 510(k) number is K171982.

When was DROPLET PEN NEEDLE approved by the FDA?

DROPLET PEN NEEDLE received FDA 510(k) clearance on 2018-03-21, under approval number K171982.

What company makes DROPLET PEN NEEDLE?

DROPLET PEN NEEDLE is manufactured by Htl-Strefa S.A.

What is the FDA product code for DROPLET PEN NEEDLE?

The FDA product code for DROPLET PEN NEEDLE is FMI.

Other Devices by Htl-Strefa S.A

K170988DropSafe Safety Pen Needle K202340Droplet Pen Needle 30G & 33G K192082Droplet Pen Needle 34G K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets K250016droplet® personal lancets

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.