FDA 510(k)

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

Número K: K231666 · 2023-12-13

RequerenteFUJIFILM Healthcare Americas Corporation

Data da decisão2023-12-13

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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