# K023694: Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Biopsy Sciences, LLC
- Decided: Mar 17, 2003 after 136 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
No predicates in its family tree.
33 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) J&J Ethicon MicroMark: named in the summary without a submission number
- (no number) Ultraclip Tissue Marker: named in the summary without a submission number
- (no number) SenoRx Gel Mark Biopsy Site Marker: named in the summary without a submission number
- (no number) Vivant Medical Biopsy Marker System: named in the summary without a submission number

## Most influential descendants
- K051421: Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor (2005), 32 descendants of its own
- K053518: Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor (2006), 31 descendants of its own
- K060769: Hydromark Biopsy Site Marker (2006), 30 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K023694
Methodology: https://510kreport.com/methodology