BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER— 510(k) K023694

Substantially Equivalent

Biopsy Sciences, LLC

FDA 510(k) clearance K023694 for BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER, Substantially Equivalent on 2003-03-17. Applicant: Biopsy Sciences, LLC.

Clearance details

Applicant: Biopsy Sciences, LLC
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2002-11-01
Decision date: 2003-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.