Company ยท US
Biopsy Sciences, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2013. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 29, 2013 | K130537 | BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Jul 12, 2012 | K121113 | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Mar 5, 2009 | K090501 | BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 Biopsy Sciences, LLC | NEU |
| Feb 9, 2009 | K083006 | BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Jul 25, 2006 | K060769 | HYDROMARK BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Jun 15, 2004 | K041331 | BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER Biopsy Sciences, LLC | GDW |
| Mar 17, 2003 | K023694 | BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER Biopsy Sciences, LLC | NEU |
| Sep 3, 2002 | K021847 | BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES Biopsy Sciences, LLC | FCG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||