FDA 510(k)

NIPRO HYPODERMIC NEEDLE

K-Number: K052474 · 2005-11-10

Decision Date2005-11-10

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NIPRO HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corp.. It received FDA 510(k) clearance on 2005-11-10 under 510(k) number K052474. 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 NIPRO HYPODERMIC NEEDLE?

NIPRO HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 2005-11-10. The listed applicant is Nipro Medical Corp.. The 510(k) number is K052474.

When did NIPRO HYPODERMIC NEEDLE receive FDA 510(k) clearance?

NIPRO HYPODERMIC NEEDLE received FDA 510(k) clearance on 2005-11-10, under 510(k) number K052474.

Who is the listed applicant for NIPRO HYPODERMIC NEEDLE?

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

What is the FDA product code for NIPRO HYPODERMIC NEEDLE?

The FDA product code for NIPRO HYPODERMIC NEEDLE is FMI.

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Other records listing Nipro Medical Corp. as applicant

K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE K081210NIPRO SAFETOUCH HUBER INFUSTION SET K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 K063368NIPRO BIOHOLE NEEDLE K063721NIPRO SAFETOUCH II GAMMA K051574NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

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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

View on FDA Database →

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