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FDA 510(k)

Sterile Aesthetic Cannula and Hypodermic Needle

K-Number: K223327 · 2023-02-16

ApplicantShanghai Kindly Enterprise Development Group Co., Ltd.
Decision Date2023-02-16
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Aesthetic Cannula and Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K223327. 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 Sterile Aesthetic Cannula and Hypodermic Needle?

Sterile Aesthetic Cannula and Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. The 510(k) number is K223327.

When did Sterile Aesthetic Cannula and Hypodermic Needle receive FDA 510(k) clearance?

Sterile Aesthetic Cannula and Hypodermic Needle received FDA 510(k) clearance on 2023-02-16, under 510(k) number K223327.

Who is the listed applicant for Sterile Aesthetic Cannula and Hypodermic Needle?

The FDA 510(k) record lists Shanghai Kindly Enterprise Development Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Aesthetic Cannula and Hypodermic Needle?

The FDA product code for Sterile Aesthetic Cannula and Hypodermic Needle is FMI.

Other records listing Shanghai Kindly Enterprise Development Group 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.

K223678Sterile Syringes for Single Use

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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