ENDOTINE RIBBON— 510(k) K051415

Substantially Equivalent

Coapt Systems, Inc.

FDA 510(k) clearance K051415 for ENDOTINE RIBBON, Substantially Equivalent on 2005-06-23. Applicant: Coapt Systems, Inc..

Clearance details

Applicant: Coapt Systems, Inc.
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2005-06-01
Decision date: 2005-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

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.