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FDA 510(k)

THINWALL PUNCTURE NEEDLE

K-Number: K841704 · 1984-06-28

ApplicantMeadox Surgimed, Inc.
Decision Date1984-06-28
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THINWALL PUNCTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1984-06-28 under 510(k) number K841704. 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 THINWALL PUNCTURE NEEDLE?

THINWALL PUNCTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1984-06-28. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K841704.

When did THINWALL PUNCTURE NEEDLE receive FDA 510(k) clearance?

THINWALL PUNCTURE NEEDLE received FDA 510(k) clearance on 1984-06-28, under 510(k) number K841704.

Who is the listed applicant for THINWALL PUNCTURE NEEDLE?

The FDA 510(k) record lists Meadox Surgimed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THINWALL PUNCTURE NEEDLE?

The FDA product code for THINWALL PUNCTURE NEEDLE is FMI.

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Other records listing Meadox Surgimed, Inc. as applicant

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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

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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