FDA 510(k)

Verisafe Safety Retractable Insulin Syringes

Número K: K250192 · 2025-12-10

RequerentePromisemed Hangzhou Meditech Co., Ltd.

Data da decisão2025-12-10

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Verisafe Safety Retractable Insulin Syringes 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 2025-12-10 under 510(k) number K250192. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Verisafe Safety Retractable Insulin Syringes?

Verisafe Safety Retractable Insulin Syringes is a medical device that received FDA 510(k) clearance on 2025-12-10. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K250192.

When did Verisafe Safety Retractable Insulin Syringes receive FDA 510(k) clearance?

Verisafe Safety Retractable Insulin Syringes received FDA 510(k) clearance on 2025-12-10, under 510(k) number K250192.

Who is the listed applicant for Verisafe Safety Retractable Insulin Syringes?

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 Verisafe Safety Retractable Insulin Syringes?

The FDA product code for Verisafe Safety Retractable Insulin Syringes is FMF.

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Fonte oficial

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