Fuse Endoscopic System with FuseBox Processor— 510(k) K160275
Substantially EquivalentEndochoice, Inc.
FDA 510(k) clearance K160275 for Fuse Endoscopic System with FuseBox Processor, Substantially Equivalent on 2016-08-01. Applicant: Endochoice, Inc.. Device class: 2.
Clearance details
- Applicant
- Endochoice, Inc.
- Product code
- Code PEA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
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More clearances from Endochoice, Inc.
view allAdverse events under product code PEA
product code PEA- Malfunction
- 515
- Total
- 515
Source: openFDA MAUDE database, through . 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.