FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM01— 510(k) K261880

Name: FDA 510(k) clearance K261880
Creator: U.S. Food and Drug Administration
Published: 2026-07-02

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K261880 for FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM01, Substantially Equivalent on 2026-07-02. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Device name as filed: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
Applicant: Fujifilm Corporation
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-06-05
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigarakami-Gun, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code FET

view all

K261260 — HD Camera Head OLYMPUS CH-S200-08-LB2026-06-24
K251734 — ProVee Video Processing Unit (PV-003)2025-09-24
K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K)2025-08-11
K250204 — Endoscopic Camera System2025-07-01
K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R2025-04-11

More clearances from Fujifilm Corporation

view all

K261170 — BA-004CC2026-08-12
K260567 — EW10-EC02 Endoscopy Support Program2026-08-07
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
K254075 — Synapse Lung Nodule AI2026-05-27
K254189 — Synapse 3D Base Tools (V7.2)2026-04-30

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.