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FDA 510(k)

INSULIN PEN NEEDLE ADAPTER

K-Number: K010887 · 2001-06-08

ApplicantOhana Needle Co.
Decision Date2001-06-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSULIN PEN NEEDLE ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Ohana Needle Co.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K010887. 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 INSULIN PEN NEEDLE ADAPTER?

INSULIN PEN NEEDLE ADAPTER is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Ohana Needle Co.. The 510(k) number is K010887.

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

INSULIN PEN NEEDLE ADAPTER received FDA 510(k) clearance on 2001-06-08, under 510(k) number K010887.

Who is the listed applicant for INSULIN PEN NEEDLE ADAPTER?

The FDA 510(k) record lists Ohana Needle Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSULIN PEN NEEDLE ADAPTER?

The FDA product code for INSULIN PEN NEEDLE ADAPTER is FMI.

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

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