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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 a medical device manufactured by Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2021-02-16 under approval 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. It is manufactured by Poonglim Pharmatech, Inc.. The 510(k) number is K210444.

When was EZ-Injec LDV Sterile Safety Needle approved by the FDA?

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

What company makes EZ-Injec LDV Sterile Safety Needle?

EZ-Injec LDV Sterile Safety Needle is manufactured by Poonglim Pharmatech, Inc..

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.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. 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 K192222EZ-Inject Single use Needle K210443PLPT LDV (Low Dead Volume) Sterile Syringe 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: QNS)

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK

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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