BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER— 510(k) K130537

Clearance details

Applicant

Biopsy Sciences, LLC

Product code

Code NEU

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2013-03-01

Decision date

2013-03-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Yorba Linda, CA, US

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• K251748 — MammoSTAR Biopsy Site Identifier2025-07-23

• K121113 — BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER2012-07-12
• K090501 — BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S12009-03-05
• K083006 — BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER2009-02-09
• K060769 — HYDROMARK BIOPSY SITE MARKER2006-07-25
• K041331 — BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER2004-06-15

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 →