Decision Date2023-06-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230635. 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 Pen Needle?
Pen Needle is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K230635.
When did Pen Needle receive FDA 510(k) clearance?
Pen Needle received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230635.
Who is the listed applicant for Pen Needle?
The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pen Needle?
The FDA product code for Pen Needle is FMI.
Other records listing Jiangsu Caina Medical 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.
View all 15 devices →
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.