FUSE 1C COLONOSCOPY SYSTEM— 510(k) K132839

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K132839 for FUSE 1C COLONOSCOPY SYSTEM, Substantially Equivalent on 2014-02-06. Applicant: Endochoice, Inc..

Clearance details

Applicant: Endochoice, Inc.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2013-09-10
Decision date: 2014-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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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 →

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