Vesocclude Polymer Ligating Clip— 510(k) K152082

Substantially Equivalent

Vesocclude Medical, LLC

FDA 510(k) clearance K152082 for Vesocclude Polymer Ligating Clip, Substantially Equivalent on 2016-02-26. Applicant: Vesocclude Medical, LLC.

Clearance details

Applicant
Vesocclude Medical, LLC
Product code
Code FZP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raleigh, NC, 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.