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FDA 510(k)

SHIELDING NEEDLE HOLDER

K-Number: K003381 · 2001-04-23

ApplicantU.S. Safety Syringes Co., Inc.
Decision Date2001-04-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHIELDING NEEDLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Safety Syringes Co., Inc.. It received FDA 510(k) clearance on 2001-04-23 under 510(k) number K003381. 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 SHIELDING NEEDLE HOLDER?

SHIELDING NEEDLE HOLDER is a medical device that received FDA 510(k) clearance on 2001-04-23. The listed applicant is U.S. Safety Syringes Co., Inc.. The 510(k) number is K003381.

When did SHIELDING NEEDLE HOLDER receive FDA 510(k) clearance?

SHIELDING NEEDLE HOLDER received FDA 510(k) clearance on 2001-04-23, under 510(k) number K003381.

Who is the listed applicant for SHIELDING NEEDLE HOLDER?

The FDA 510(k) record lists U.S. Safety Syringes Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIELDING NEEDLE HOLDER?

The FDA product code for SHIELDING NEEDLE HOLDER is FMI.

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Other records listing U.S. Safety Syringes Co., Inc. as applicant

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K090502NOVA SAFE SCALP VEIN BLOOD COLLECTION SETK090122NUOVOGUARDK083454NUOVOCATHK080665NOVOLETK080660IV ADMINISTRATION SETK990831SUPERGUARD SAFETY SYRINGE

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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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