# K060769: Hydromark Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Biopsy Sciences, LLC
- Decided: Jul 25, 2006 after 125 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K023694 (2003). 5 ancestors in all.
30 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023694: Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker, Biopsy Sciences, LLC (2003) Summary page 1.
- K041331: Biopsy Sciences, LLC, Lung Biopsy Site Marker, Biopsy Sciences, LLC (2004) Summary page 1.
- K053518: Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor, Medical Device Technologies, Inc. (2006) Summary page 1.
- K970817: Micromark Clip, Biopsys Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K083006: Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker (2009), 28 descendants of its own
- 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), 27 descendants of its own
- K120804: Cianna Medical Tissue Marker and Delivery System (2013), 15 descendants of its own
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm (2016), 13 descendants of its own
- K163541: Magseed Magnetic Marker System (2017), 12 descendants of its own

## Indications for use
The Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

Source page: https://510kreport.com/device/K060769
Methodology: https://510kreport.com/methodology