510(k) K031832— MEGA PURE CART

Substantially Equivalent

Mega Services

Clearance details

Applicant: Mega Services
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2003-06-13
Decision date: 2004-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cibolo, TX, US

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.