DUAL NEEDLE SUTURE PASSER SYSTEM— 510(k) K082518

Substantially Equivalent

Cayenne Medical, Inc.

FDA 510(k) clearance K082518 for DUAL NEEDLE SUTURE PASSER SYSTEM, Substantially Equivalent on 2009-01-16. Applicant: Cayenne Medical, Inc..

Clearance details

Applicant: Cayenne Medical, Inc.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2008-09-02
Decision date: 2009-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.