Fuse Endoscopic System with FuseBox Processor— 510(k) K160275

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K160275 for Fuse Endoscopic System with FuseBox Processor, Substantially Equivalent on 2016-08-01. Applicant: Endochoice, Inc..

Clearance details

Applicant: Endochoice, Inc.
Product code: Code PEA
Advisory panel: Gastroenterology, Urology
Date received: 2016-02-02
Decision date: 2016-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PEA

product code PEA

Malfunction: 515
Total: 515

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.