Cerdak Basic— 510(k) K153138

Substantially Equivalent

Bu Polysciences Equipment & Trading, LLC

FDA 510(k) clearance K153138 for Cerdak Basic, Substantially Equivalent on 2017-06-23. Applicant: Bu Polysciences Equipment & Trading, LLC.

Clearance details

Applicant: Bu Polysciences Equipment & Trading, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2015-10-30
Decision date: 2017-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.