FDA 510(k)

NON-CORNING (HUBER) NEEDLE

K-Number: K936029 · 1994-02-04

Decision Date1994-02-04

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-CORNING (HUBER) NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1994-02-04 under 510(k) number K936029. 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 NON-CORNING (HUBER) NEEDLE?

NON-CORNING (HUBER) NEEDLE is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Therex Corp.. The 510(k) number is K936029.

When did NON-CORNING (HUBER) NEEDLE receive FDA 510(k) clearance?

NON-CORNING (HUBER) NEEDLE received FDA 510(k) clearance on 1994-02-04, under 510(k) number K936029.

Who is the listed applicant for NON-CORNING (HUBER) NEEDLE?

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

What is the FDA product code for NON-CORNING (HUBER) NEEDLE?

The FDA product code for NON-CORNING (HUBER) NEEDLE is FMI.

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Other records listing Therex Corp. as applicant

K953110LOW PROFILE TITANIUM MODEL CATALOG #1003 K953017LOW PROFILE TITANIUM MODEL CATALOG #1003 K952537THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.K950212A2 DETACHED DUAL PORT SYSTEM K9501311.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL K942412THEREX LOW-PROFILE PORT - TITANIUM MODEL

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Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed 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.