BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER— 510(k) K041331

Substantially Equivalent

Biopsy Sciences, LLC

FDA 510(k) clearance K041331 for BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER, Substantially Equivalent on 2004-06-15. Applicant: Biopsy Sciences, LLC.

Clearance details

Applicant: Biopsy Sciences, LLC
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2004-05-19
Decision date: 2004-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.