CARIS SITE MARKER— 510(k) K003777

Substantially Equivalent

Artemis Medical, Inc.

FDA 510(k) clearance K003777 for CARIS SITE MARKER, Substantially Equivalent on 2001-03-06. Applicant: Artemis Medical, Inc..

Clearance details

Applicant: Artemis Medical, Inc.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2000-12-07
Decision date: 2001-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, 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.