# Biopsy Sciences, LLC

- Location (FDA's records): Yorba Linda, CA
- FDA decisions: 8 (2002–2013): 8 510(k) clearances
- Product codes: NEU (6), FCG (1), GDW (1)
- Predicates its devices cite: 16 (12 its own); citations of its devices by later devices: 21 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sherwood Medical Co.: 1 (https://510kreport.com/company/sherwood-medical)
- Manan Manufacturing Co., Inc.: 1 (https://510kreport.com/company/manan-manufacturing)
- Medical Device Technologies, Inc.: 1 (https://510kreport.com/company/medical-device-technologies)
- Biopsys Medical, Inc.: 1 (https://510kreport.com/company/biopsys-medical)

## Firms that cite its devices most
- Devicor Medical Products, Inc.: 3 (https://510kreport.com/company/devicor-medical-products)
- View Point Medical, Inc.: 2 (https://510kreport.com/company/view-point-medical)
- Pneumrx, Inc.: 1 (https://510kreport.com/company/pneumrx)
- Cianna Medical, Inc.: 1 (https://510kreport.com/company/cianna-medical)
- Cook Ireland, Ltd.: 1 (https://510kreport.com/company/cook-ireland)
- Medical Device Technologies, Inc.: 1 (https://510kreport.com/company/medical-device-technologies)

## Its most-cited devices
- K060769: Hydromark Biopsy Site Marker (2006), cited by 5
- K083006: Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker (2009), cited by 3
- K121113: Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker (2012), cited by 3
- 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 (2009), cited by 3
- K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (2002), cited by 2
- K041331: Biopsy Sciences, LLC, Lung Biopsy Site Marker (2004), cited by 2

## Recent decisions
- K130537: Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker (Mar 29, 2013)
- K121113: Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker (Jul 12, 2012)
- 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 (Mar 5, 2009)
- K083006: Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker (Feb 9, 2009)
- K060769: Hydromark Biopsy Site Marker (Jul 25, 2006)
- K041331: Biopsy Sciences, LLC, Lung Biopsy Site Marker (Jun 15, 2004)
- K023694: Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker (Mar 17, 2003)
- K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (Sep 3, 2002)

Source page: https://510kreport.com/company/biopsy-sciences