Decision Date2023-03-20
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Shina Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shina Corporation. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K222417. 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 Shina Safety Needle?
Shina Safety Needle is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Shina Corporation. The 510(k) number is K222417.
When did Shina Safety Needle receive FDA 510(k) clearance?
Shina Safety Needle received FDA 510(k) clearance on 2023-03-20, under 510(k) number K222417.
Who is the listed applicant for Shina Safety Needle?
The FDA 510(k) record lists Shina Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Shina Safety Needle?
The FDA product code for Shina Safety Needle is FMI.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.