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FDA 510(k)

EZ-Inject Single use Needle

K-Number: K192222 · 2020-05-12

ApplicantPoonglim Pharmatech, Inc.
Decision Date2020-05-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-Inject Single use Needle is a medical device manufactured by Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2020-05-12 under approval number K192222. 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 EZ-Inject Single use Needle?

EZ-Inject Single use Needle is a medical device that received FDA 510(k) clearance on 2020-05-12. It is manufactured by Poonglim Pharmatech, Inc.. The 510(k) number is K192222.

When was EZ-Inject Single use Needle approved by the FDA?

EZ-Inject Single use Needle received FDA 510(k) clearance on 2020-05-12, under approval number K192222.

What company makes EZ-Inject Single use Needle?

EZ-Inject Single use Needle is manufactured by Poonglim Pharmatech, Inc..

What is the FDA product code for EZ-Inject Single use Needle?

The FDA product code for EZ-Inject Single use Needle is FMI.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Poonglim Pharmatech, Inc.

K172483Kopac Sterile Needle K210443PLPT LDV (Low Dead Volume) Sterile Syringe K210444EZ-Injec LDV Sterile Safety Needle K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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