# K132463: Cianna Medical Permanent Tissue Marker and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical, Inc.
- Decided: Dec 3, 2013 after 118 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: 7 generations back to K023694 (2003). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120804: Cianna Medical Tissue Marker and Delivery System, Cianna Medical (2013) Summary page 1.
- K102506: Mixed Media Marker, Cortex Manufacturing, Inc. (2011) Summary page 1.
- K111692: Tumark Flex for Mammotome,Tumark Flex for Atec, Somatex Medical Technologies GmbH (2011) Summary page 3.

## Indications for use
The Cianna Medical Permanent Tissue Marker is intended to mark tissue during a percutaneous breast biopsy procedure and be permanently visible by radiography and visible for up to thirty days by ultrasound.

Source page: https://510kreport.com/device/K132463
Methodology: https://510kreport.com/methodology