# K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Bioform, Inc.
- Decided: Oct 22, 2001 after 48 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: 2 generations back to K970817 (1997). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001807: Tissue Marker, Advanced Uroscience, Inc. (2001) Summary page 2.
- K000060: Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007, Senorx, Inc. (2000) Summary page 2.
- K983400: Auto Suture Site Marker Clip, United States Surgical, A Division of Tyco Healthc (1999) Summary page 2.

## Most influential descendants
- K072219: Cytophil Tissue Marker (2008), 10 descendants of its own
- K093473: KMD-MARK1 Tissue Marker (2010), 9 descendants of its own
- K130763: Beacon Tissue Marker (2013), 5 descendants of its own
- K140835: General and Plastic Surgery (2014), 3 descendants of its own
- K133697: Breast-Med Tissue Marker (2015), 1 descendant of its own

## Indications for use
Coaptite™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K012955
Methodology: https://510kreport.com/methodology