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FDA 510(k)

Articulador Injection Needle (00711807), Articulador Injection Needle (00711810), Articulador Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)

N.º K: K232826 · 2024-03-08

SolicitanteSteris
Fecha de decisión2024-03-08
Código de productoFBK
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K232826. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)?

Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Steris. The 510(k) number is K232826.

When did Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) receive FDA 510(k) clearance?

Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K232826.

Who is the listed applicant for Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)?

The FDA 510(k) record lists Steris as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)?

The FDA product code for Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) is FBK.

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Dispositivos relacionados (Código: FBK)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

Fuente oficial

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