Droplet Pen Needle 34G
K-Number: K192082 · 2020-04-21
ApplicantHtl-Strefa S.A
Decision Date2020-04-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Droplet Pen Needle 34G is a medical device manufactured by Htl-Strefa S.A. It received FDA 510(k) clearance on 2020-04-21 under approval number K192082. 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 34G?
Droplet Pen Needle 34G is a medical device that received FDA 510(k) clearance on 2020-04-21. It is manufactured by Htl-Strefa S.A. The 510(k) number is K192082.
When was Droplet Pen Needle 34G approved by the FDA?
Droplet Pen Needle 34G received FDA 510(k) clearance on 2020-04-21, under approval number K192082.
What company makes Droplet Pen Needle 34G?
Droplet Pen Needle 34G is manufactured by Htl-Strefa S.A.
What is the FDA product code for Droplet Pen Needle 34G?
The FDA product code for Droplet Pen Needle 34G is FMI.
Other Devices by Htl-Strefa S.A
K170988DropSafe Safety Pen Needle
K171982DROPLET PEN NEEDLE
K202340Droplet Pen Needle 30G & 33G
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
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.