FDA 510(k)

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

N.º K: K231666 · 2023-12-13

SolicitanteFUJIFILM Healthcare Americas Corporation

Fecha de decisión2023-12-13

Código de productoITX

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K231666. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)?

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231666.

When did Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) receive FDA 510(k) clearance?

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231666.

Who is the listed applicant for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)?

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

What is the FDA product code for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)?

The FDA product code for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is ITX.

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Fuente oficial

Ver en la base de datos de la FDA →

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