GUARDIAN CONNECTION— 510(k) K101214

Substantially Equivalent

Maulin Medical, LLC

FDA 510(k) clearance K101214 for GUARDIAN CONNECTION, Substantially Equivalent on 2010-07-23. Applicant: Maulin Medical, LLC.

Clearance details

Applicant: Maulin Medical, LLC
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 2010-04-30
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pueblo West, CO, 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.