FDA 510(k)

Endoscopic Injection Needles

Número K: K240675 · 2024-10-04

RequerentePromisemed Hangzhou Meditech Co., Ltd.

Data da decisão2024-10-04

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endoscopic Injection Needles 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 2024-10-04 under 510(k) number K240675. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Endoscopic Injection Needles?

Endoscopic Injection Needles is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K240675.

When did Endoscopic Injection Needles receive FDA 510(k) clearance?

Endoscopic Injection Needles received FDA 510(k) clearance on 2024-10-04, under 510(k) number K240675.

Who is the listed applicant for Endoscopic Injection Needles?

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 Endoscopic Injection Needles?

The FDA product code for Endoscopic Injection Needles is FBK.

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K261719Promisemed X-Safety Pen Needle K261196Promisemed VeriEcto Automatic Biopsy Needles K261045Verifine Safety Lancets K254273Verisafe Safety Sterile Needles (SSN)K250192Verisafe Safety Retractable Insulin Syringes K250961Blood collection tube holders

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Dispositivos Relacionados (Código: FBK)

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.

Fonte oficial

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