FDA 510(k)

Dispositivo de Biopsia por Punción Fina con Ultrasonido Endoscópico Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB)

N.º K: K223616 · 2022-12-30

SolicitanteBoston Scientific Corporation

Fecha de decisión2022-12-30

Código de productoODG

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K223616. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Boston Scientific Corporation. The 510(k) number is K223616.

When did Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device receive FDA 510(k) clearance?

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device received FDA 510(k) clearance on 2022-12-30, under 510(k) number K223616.

Who is the listed applicant for Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

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

What is the FDA product code for Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device?

The FDA product code for Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is ODG.

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Fuente oficial

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