# K970817: Micromark Clip

- Pathway: 510(k) (Traditional)
- Applicant: Biopsys Medical, Inc.
- Decided: Sep 11, 1997 after 189 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.
78 later devices descend from it; 4 cite it directly.
0 of 79 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) BMI Surgical Staple Marker: named in the summary without a submission number

## Most influential descendants
- K983400: Auto Suture Site Marker Clip (1999), 35 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
- K993785: Ultraclip Tissue Marker (2000), 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 MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location. It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.

Source page: https://510kreport.com/device/K970817
Methodology: https://510kreport.com/methodology