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FDA 510(k)

Kopac Sterile Needle

K-Number: K172483 · 2018-06-21

ApplicantPoonglim Pharmatech, Inc.
Decision Date2018-06-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Kopac Sterile Needle is the device name listed in this FDA 510(k) record. The listed applicant is Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K172483. 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 Kopac Sterile Needle?

Kopac Sterile Needle is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K172483.

When did Kopac Sterile Needle receive FDA 510(k) clearance?

Kopac Sterile Needle received FDA 510(k) clearance on 2018-06-21, under 510(k) number K172483.

Who is the listed applicant for Kopac Sterile Needle?

The FDA 510(k) record lists Poonglim Pharmatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kopac Sterile Needle?

The FDA product code for Kopac Sterile Needle is FMI.

Other records listing Poonglim Pharmatech, Inc. 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.

K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringeK221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringeK210444EZ-Injec LDV Sterile Safety NeedleK210443PLPT LDV (Low Dead Volume) Sterile SyringeK192222EZ-Inject Single use 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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