FROG— 510(k) K072831

Substantially Equivalent

Newby-Coombs, LLC

FDA 510(k) clearance K072831 for FROG, Substantially Equivalent on 2008-12-12. Applicant: Newby-Coombs, LLC.

Clearance details

Applicant: Newby-Coombs, LLC
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 2007-10-03
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchville, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.