MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE— 510(k) K020470

Substantially Equivalent

Bypass , Ltd.

FDA 510(k) clearance K020470 for MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE, Substantially Equivalent on 2002-03-08. Applicant: Bypass , Ltd..

Clearance details

Applicant: Bypass , Ltd.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2002-02-12
Decision date: 2002-03-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

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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.