Biopsy Sciences, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Biopsy Sciences, LLC” (first 2002, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 91 |
| 2013 | 1 | 28 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 6 | 6 |
| FCG | Biopsy Needle | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
Review panels
Most recent Biopsy Sciences, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130537 | BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER | NEU | 2013-03-29 | 28 |
| K121113 | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER | NEU | 2012-07-12 | 91 |
| 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 | NEU | 2009-03-05 | 8 |
| K083006 | BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER | NEU | 2009-02-09 | 124 |
| K060769 | HYDROMARK BIOPSY SITE MARKER | NEU | 2006-07-25 | 125 |
| K041331 | BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER | GDW | 2004-06-15 | 27 |
| K023694 | BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER | NEU | 2003-03-17 | 136 |
| K021847 | BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES | FCG | 2002-09-03 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Biopsy Sciences, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biopsy Sciences, LLC (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Biopsy Sciences, LLC?
FDA lists 8 510(k) clearances under the applicant name “Biopsy Sciences, LLC” (first 2002, latest 2013), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biopsy Sciences, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biopsy Sciences, LLC is 90 days.
Which FDA product codes appear under Biopsy Sciences, LLC?
The most frequent FDA product codes under this applicant name are NEU (Marker, Radiographic, Implantable, 6); FCG (Biopsy Needle, 1); GDW (Staple, Implantable, 1).
Next steps
- See all 8 Biopsy Sciences, LLC clearances with predicates and recalls
- Run predicate analysis for product code NEU, Biopsy Sciences, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.