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FUJIFILM

FUJIFILM CORPORATION · Model SB-601 · UDI-DI 04547410339437

FFY Prescription

510(k) clearances

Adverse events

Recalls

103

Facilities

Description

This device is intended to be installed into the suction valve on the control portion of our ultrasonic endoscope in order to switch suck operation and balloon suck operation selectively. Do not use this product for any other purpose.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.