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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2020-04-21 under 510(k) 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. The listed applicant is Htl-Strefa S.A. The 510(k) number is K192082.

When did Droplet Pen Needle 34G receive FDA 510(k) clearance?

Droplet Pen Needle 34G received FDA 510(k) clearance on 2020-04-21, under 510(k) number K192082.

Who is the listed applicant for Droplet Pen Needle 34G?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Droplet Pen Needle 34G?

The FDA product code for Droplet Pen Needle 34G is FMI.

Other records listing Htl-Strefa S.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250016droplet® personal lancetsK220643DropSafe 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 LancetsK202340Droplet Pen Needle 30G & 33GK171982DROPLET PEN NEEDLEK170988DropSafe Safety Pen Needle

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

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.

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