# K041331: Biopsy Sciences, LLC, Lung Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Biopsy Sciences, LLC
- Decided: Jun 15, 2004 after 27 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 2 cite it directly.
0 of 33 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) Biopsy Sciences Bio-MARK Biopsy Site Marker: named in the summary without a submission number
- (no number) J&J Ethicon MicroMark: 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) Artemis CoreMARK/MegaMARK Biopsy Site Identifier: named in the summary without a submission number
- (no number) Vivant Medical Biopsy Marker System: named in the summary without a submission number
- (no number) Medical Device Technologies Aspiration and Injection Needle: named in the summary without a submission number

## Most influential descendants
- 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
- 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

## Indications for use
The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Source page: https://510kreport.com/device/K041331
Methodology: https://510kreport.com/methodology