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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 a medical device manufactured by Poonglim Pharmatech, Inc.. It received FDA 510(k) clearance on 2018-06-21 under approval 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. It is manufactured by Poonglim Pharmatech, Inc.. The 510(k) number is K172483.

When was Kopac Sterile Needle approved by the FDA?

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

What company makes Kopac Sterile Needle?

Kopac Sterile Needle is manufactured by Poonglim Pharmatech, Inc..

What is the FDA product code for Kopac Sterile Needle?

The FDA product code for Kopac Sterile Needle is FMI.

Related Clinical Trials

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.

K192222EZ-Inject Single use 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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