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FDA 510(k)

Insulin Syringe

K-Number: K193273 · 2021-01-05

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2021-01-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin Syringe is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under approval number K193273. 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 2021-01-05. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K193273.

When was Insulin Syringe approved by the FDA?

Insulin Syringe received FDA 510(k) clearance on 2021-01-05, under approval number K193273.

What company makes Insulin Syringe?

Insulin Syringe is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Insulin Syringe?

The FDA product code for Insulin Syringe is FMF.

Related Clinical Trials

NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle

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Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

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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