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FDA 510(k)

NON-CORING NEEDLE

K-Number: K960698 · 1996-04-15

ApplicantMed Institute, Inc.
Decision Date1996-04-15
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-CORING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Med Institute, Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K960698. 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-CORING NEEDLE?

NON-CORING NEEDLE is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Med Institute, Inc.. The 510(k) number is K960698.

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

NON-CORING NEEDLE received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960698.

Who is the listed applicant for NON-CORING NEEDLE?

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

What is the FDA product code for NON-CORING NEEDLE?

The FDA product code for NON-CORING NEEDLE is FMI.

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Other records listing Med Institute, 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.

K990034WILSON-COOK COLONIC Z-STENTK982507MINI POLYURETHANE CATHETERK981061INTRAVASCULAR RETRIEVAL DEVICEK964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEMK971140VITAL-PORT INFUSION PALK970442TARGET VITAL-PORT VASCULAR ACCESS SYSTEM

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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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