HALO 360 & SIZING BALLOON, MODEL 3441C— 510(k) K093855

Substantially Equivalent

Barrx Medical, Incorporated

FDA 510(k) clearance K093855 for HALO 360 & SIZING BALLOON, MODEL 3441C, Substantially Equivalent on 2010-01-15. Applicant: Barrx Medical, Incorporated.

Clearance details

Applicant: Barrx Medical, Incorporated
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2009-12-16
Decision date: 2010-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.