FUJINON ULTRASONIC PROCESSOR— 510(k) K111243

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K111243 for FUJINON ULTRASONIC PROCESSOR, Substantially Equivalent on 2011-05-16. Applicant: Fujinon, Inc..

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2011-05-03
Decision date: 2011-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Stamford, CT, US

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Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.