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FDA 510(k)

EZ-Injec LDV Sterile Safety Needle

K-Number: K210444 · 2021-02-16

ApplicantPoonglim Pharmatech, Inc.
Decision Date2021-02-16
Product CodeQNS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-Injec LDV Sterile Safety 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 2021-02-16 under 510(k) number K210444. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-Injec LDV Sterile Safety Needle?

EZ-Injec LDV Sterile Safety Needle is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Poonglim Pharmatech, Inc.. The 510(k) number is K210444.

When did EZ-Injec LDV Sterile Safety Needle receive FDA 510(k) clearance?

EZ-Injec LDV Sterile Safety Needle received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210444.

Who is the listed applicant for EZ-Injec LDV Sterile Safety 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 EZ-Injec LDV Sterile Safety Needle?

The FDA product code for EZ-Injec LDV Sterile Safety Needle is QNS.

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 SyringeK210443PLPT LDV (Low Dead Volume) Sterile SyringeK192222EZ-Inject Single use NeedleK172483Kopac Sterile Needle

Related Devices (Code: QNS)

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.

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLCK231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK

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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