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FDA 510(k)

PUSH-ON NEEDLE 30GX8MM

K-Number: K120191 · 2012-05-23

ApplicantScandinavian Health Limited
Decision Date2012-05-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUSH-ON NEEDLE 30GX8MM is the device name listed in this FDA 510(k) record. The listed applicant is Scandinavian Health Limited. It received FDA 510(k) clearance on 2012-05-23 under 510(k) number K120191. 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 PUSH-ON NEEDLE 30GX8MM?

PUSH-ON NEEDLE 30GX8MM is a medical device that received FDA 510(k) clearance on 2012-05-23. The listed applicant is Scandinavian Health Limited. The 510(k) number is K120191.

When did PUSH-ON NEEDLE 30GX8MM receive FDA 510(k) clearance?

PUSH-ON NEEDLE 30GX8MM received FDA 510(k) clearance on 2012-05-23, under 510(k) number K120191.

Who is the listed applicant for PUSH-ON NEEDLE 30GX8MM?

The FDA 510(k) record lists Scandinavian Health Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUSH-ON NEEDLE 30GX8MM?

The FDA product code for PUSH-ON NEEDLE 30GX8MM 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 Scandinavian Health Limited 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.

K124026LOBSTER AUTO-INJECTOR

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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