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FDA 510(k)

NEEDLEGARD II

K-Number: K920717 · 1992-04-22

ApplicantIngenious Technologies Corp.
Decision Date1992-04-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLEGARD II is the device name listed in this FDA 510(k) record. The listed applicant is Ingenious Technologies Corp.. It received FDA 510(k) clearance on 1992-04-22 under 510(k) number K920717. 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 NEEDLEGARD II?

NEEDLEGARD II is a medical device that received FDA 510(k) clearance on 1992-04-22. The listed applicant is Ingenious Technologies Corp.. The 510(k) number is K920717.

When did NEEDLEGARD II receive FDA 510(k) clearance?

NEEDLEGARD II received FDA 510(k) clearance on 1992-04-22, under 510(k) number K920717.

Who is the listed applicant for NEEDLEGARD II?

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

What is the FDA product code for NEEDLEGARD II?

The FDA product code for NEEDLEGARD II is FMI.

Related Clinical Trials

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.

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Other records listing Ingenious Technologies Corp. 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.

K936235NEEDLESAFE II & NEEDLEGARD II

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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