IMPLANTABLE CLIP— 510(k) K100090

Substantially Equivalent

Genicon

FDA 510(k) clearance K100090 for IMPLANTABLE CLIP, Substantially Equivalent on 2010-02-02. Applicant: Genicon.

Clearance details

Applicant: Genicon
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2010-01-12
Decision date: 2010-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Winter Park, FL, US

Download summary PDF View 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, 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.