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FDA 510(k)

CLICKFINE PEN NEEDLE

K-Number: K122969 · 2012-10-25

ApplicantP/L Biomedical
Decision Date2012-10-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLICKFINE PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is P/L Biomedical. It received FDA 510(k) clearance on 2012-10-25 under 510(k) number K122969. 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 CLICKFINE PEN NEEDLE?

CLICKFINE PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2012-10-25. The listed applicant is P/L Biomedical. The 510(k) number is K122969.

When did CLICKFINE PEN NEEDLE receive FDA 510(k) clearance?

CLICKFINE PEN NEEDLE received FDA 510(k) clearance on 2012-10-25, under 510(k) number K122969.

Who is the listed applicant for CLICKFINE PEN NEEDLE?

The FDA 510(k) record lists P/L Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLICKFINE PEN NEEDLE?

The FDA product code for CLICKFINE PEN NEEDLE is FMI.

Related Clinical Trials

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.

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Other records listing P/L Biomedical 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.

K122971CLICKFINE PEN NEEDLEK972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.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.

Official Source

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