DeviceClearance

LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM— 510(k) K080158

Substantially Equivalent

Lb Medical LLC

FDA 510(k) clearance K080158 for LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM, Substantially Equivalent on 2008-05-02. Applicant: Lb Medical LLC.

Clearance details

Applicant
Lb Medical LLC
Product code
Code FZW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alexandria, VA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FZW

product code FZW
Malfunction
3,067
Total
3,067

Source: openFDA MAUDE database, through . 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.