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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 a medical device manufactured by Shanghai Kindly Enterprise Development Group Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under approval 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. It is manufactured by Shanghai Kindly Enterprise Development Group Co., Ltd.. The 510(k) number is K223327.

When was Sterile Aesthetic Cannula and Hypodermic Needle approved by the FDA?

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

What company makes Sterile Aesthetic Cannula and Hypodermic Needle?

Sterile Aesthetic Cannula and Hypodermic Needle is manufactured by Shanghai Kindly Enterprise Development Group Co., Ltd..

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.

Related Clinical Trials

NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT07542132 The Effects of Hyaluronic Acid on Skin Health NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Shanghai Kindly Enterprise Development Group Co., Ltd.

K223678Sterile Syringes for Single Use

Related Devices (Code: FMI)

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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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