K121113

Substantially Equivalent

BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER

Applicant: Biopsy Sciences, LLC
Product code: NEU
Advisory panel: General, Plastic Surgery
Date received: 2012-04-12
Decision date: 2012-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, FL, US

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.