Medical Device Manufacturer · US , Yorba Linda , CA

Biopsy Sciences, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2002

Recent clearances: BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER, BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER, BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biopsy Sciences, LLC General & Plastic Surgery ✕

7 devices

1-7 of 7

Cleared Mar 29, 2013

BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER

General & Plastic Surgery · 28d

Cleared Jul 12, 2012

BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER

General & Plastic Surgery · 91d

Cleared Mar 05, 2009

BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1,...

General & Plastic Surgery · 8d

Cleared Feb 09, 2009

BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER

General & Plastic Surgery · 124d

Cleared Jul 25, 2006

HYDROMARK BIOPSY SITE MARKER

General & Plastic Surgery · 125d

Cleared Jun 15, 2004

BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER

General & Plastic Surgery · 27d

Cleared Mar 17, 2003

BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER

General & Plastic Surgery · 136d