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FDA 510(k)

Insulin Syringe

K-Number: K223453 · 2023-03-02

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2023-03-02
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223453. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insulin Syringe?

Insulin Syringe is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K223453.

When did Insulin Syringe receive FDA 510(k) clearance?

Insulin Syringe received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223453.

Who is the listed applicant for Insulin Syringe?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulin Syringe?

The FDA product code for Insulin Syringe is FMF.

Other records listing Promisemed Hangzhou Meditech 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.

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Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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