FUSE COLONOSCOPY SYSTEM— 510(k) K141598

Name: FDA 510(k) clearance K141598
Creator: U.S. Food and Drug Administration
Published: 2014-09-30

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K141598 for FUSE COLONOSCOPY SYSTEM, Substantially Equivalent on 2014-09-30. Applicant: Endochoice, Inc.. Device class: 2.

Clearance details

Applicant: Endochoice, Inc.
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2014-06-13
Decision date: 2014-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Endochoice, Inc.

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K160275 — Fuse Endoscopic System with FuseBox Processor2016-08-01
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K161167 — Seal Single-Use Biopsy Valve2016-05-26
K160403 — SmartStart Air/Water and Suction Valves2016-05-19
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Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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 →

Recalls naming K141598

K-number listed on FDA's recall record

Z-0694-2016 — Fuse 1C ColonoscopeClass II·Terminated·EndoChoice, Inc.·20151218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141598.

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