# K983400: Auto Suture Site Marker Clip

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Feb 10, 1999 after 135 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
Longest line of descent: 1 generation back to K970817 (1997). 1 ancestor in all.
35 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970817: Micromark Clip, Biopsys Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K022326: Radiomed Marker (2003), 21 descendants of its own
- K031206: Radiomed Soft Tissue Marker (2003), 20 descendants of its own
- K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker (2001), 12 descendants of its own
- K070305: Pre-Loaded Visicoil (2007), 11 descendants of its own
- K072219: Cytophil Tissue Marker (2008), 10 descendants of its own

## Indications for use
The Auto Suture* Site Marker** staple is intended for use in soft tissue during an open or percutaneous biopsy procedure to radiographically mark the biopsy location.

Source page: https://510kreport.com/device/K983400
Methodology: https://510kreport.com/methodology