FDA 510(k)

DropSafe Safety Pen Needle

K-Number: K170988 · 2017-12-12

Decision Date2017-12-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DropSafe Safety Pen Needle is a medical device manufactured by Htl-Strefa S.A. It received FDA 510(k) clearance on 2017-12-12 under approval number K170988. 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 DropSafe Safety Pen Needle?

DropSafe Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2017-12-12. It is manufactured by Htl-Strefa S.A. The 510(k) number is K170988.

When was DropSafe Safety Pen Needle approved by the FDA?

DropSafe Safety Pen Needle received FDA 510(k) clearance on 2017-12-12, under approval number K170988.

What company makes DropSafe Safety Pen Needle?

DropSafe Safety Pen Needle is manufactured by Htl-Strefa S.A.

What is the FDA product code for DropSafe Safety Pen Needle?

The FDA product code for DropSafe Safety Pen Needle is FMI.

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Related PubMed Literature

PMID: 30016051 General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order. Federal register (2018)

Other Devices by Htl-Strefa S.A

K171982DROPLET 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.