BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1— 510(k) K090501

Substantially Equivalent

Biopsy Sciences, LLC

FDA 510(k) clearance K090501 for BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1, Substantially Equivalent on 2009-03-05. Applicant: Biopsy Sciences, LLC.

Clearance details

Applicant: Biopsy Sciences, LLC
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2009-02-25
Decision date: 2009-03-05
Decision: Substantially Equivalent
Clearance type: Special
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.