BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER— 510(k) K083006

Substantially Equivalent

Biopsy Sciences, LLC

FDA 510(k) clearance K083006 for BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER, Substantially Equivalent on 2009-02-09. Applicant: Biopsy Sciences, LLC.

Clearance details

Applicant: Biopsy Sciences, LLC
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2008-10-08
Decision date: 2009-02-09
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.