Fujifilm Corporation - FDA 510(k) Cleared Devices

Cleared Mar 09, 2026

FUJIFILM Endoscope Model ED-S100TP

K251861 · FDT

Gastroenterology & Urology · 265d

Cleared Feb 17, 2026

FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit

K250550 · FDS

Gastroenterology & Urology · 357d

Cleared Feb 06, 2026

Hood DH-084STR

K253568 · FDS

Gastroenterology & Urology · 81d

Cleared Jun 10, 2025

FUJIFILM Endoscope Model EG-840N

K243512 · FDS

Gastroenterology & Urology · 210d

Cleared May 23, 2025

FUJIFILM Endoscope Model EC-860P/M

K243261 · FDF

Gastroenterology & Urology · 220d

Cleared Apr 11, 2025

FUJIFILM Processor EP-8000

K243260 · FET

Gastroenterology & Urology · 178d

Cleared Nov 01, 2024

Over-tube (TR-1108A)

K243091 · FED

Gastroenterology & Urology · 32d

Cleared Oct 11, 2024

Hood (DH-083ST)

K242779 · FDS

Gastroenterology & Urology · 28d

Cleared Sep 04, 2024

FUJIFILM Endoscope Model EG-840N

K240142 · FDS

Gastroenterology & Urology · 230d

Cleared Dec 15, 2023

EW10-EC02 Endoscopy Support Program

K230751 · QNP

Gastroenterology & Urology · 273d

Cleared Sep 08, 2023

FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01

K223827 · FDF

Gastroenterology & Urology · 261d

Cleared Aug 19, 2022

FUJIFILM Ultrasonic Endoscope EG-740UT

K221238 · ODG

Gastroenterology & Urology · 112d