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FDA 510(k)

Disposable Medical Safety Hypodermic Needle

K-Number: K220603 · 2022-08-23

ApplicantHantech Medical Device Co., Ltd.
Decision Date2022-08-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Safety Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K220603. 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 Disposable Medical Safety Hypodermic Needle?

Disposable Medical Safety Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K220603.

When did Disposable Medical Safety Hypodermic Needle receive FDA 510(k) clearance?

Disposable Medical Safety Hypodermic Needle received FDA 510(k) clearance on 2022-08-23, under 510(k) number K220603.

Who is the listed applicant for Disposable Medical Safety Hypodermic Needle?

The FDA 510(k) record lists Hantech Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Safety Hypodermic Needle?

The FDA product code for Disposable Medical Safety Hypodermic Needle is FMI.

Other records listing Hantech Medical Device Co., Ltd. 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.

K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)K222739Disposable Insulin Pen NeedleK222672Disposable Insulin SyringeK221038Disposable Medical Masks

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.

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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., 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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