IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677— 510(k) K051125

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K051125 for IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677, Substantially Equivalent on 2005-06-08. Applicant: Abbott Laboratories.

Clearance details

Applicant
Abbott Laboratories
Product code
Code FZP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Redwood, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FZP

product code FZP
Death
11
Injury
726
Malfunction
10,830
Other
1
Total
11,568

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.