Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T— 510(k) K143556
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K143556 for Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Substantially Equivalent on 2015-08-20. Applicant: Fujifilm Medical Systems U.S.A, Inc..
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code FDA
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Adverse events under product code FDA
product code FDA- Death
- 8
- Injury
- 148
- Total
- 156
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.