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FDA 510(k)

LO-CORE NEEDLE

K-Number: K882064 · 1988-07-08

ApplicantDevice Labs, Inc.
Decision Date1988-07-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LO-CORE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Device Labs, Inc.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K882064. 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 LO-CORE NEEDLE?

LO-CORE NEEDLE is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Device Labs, Inc.. The 510(k) number is K882064.

When did LO-CORE NEEDLE receive FDA 510(k) clearance?

LO-CORE NEEDLE received FDA 510(k) clearance on 1988-07-08, under 510(k) number K882064.

Who is the listed applicant for LO-CORE NEEDLE?

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

What is the FDA product code for LO-CORE NEEDLE?

The FDA product code for LO-CORE NEEDLE is FMI.

Related Clinical Trials

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Other records listing Device Labs, Inc. 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.

K930632CHEMOSITE IMPLANTABLE DRUG DELIVERYK904417CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEMK902135PERCUTANEOUS INTRODUCER KITK901722CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMK883764INTRAVASCULAR ADMINISTRATION SET

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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