# K120804: Cianna Medical Tissue Marker and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical
- Decided: Feb 4, 2013 after 325 days
- Product code: PBY (Temporary Tissue Marker)
- 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: 6 generations back to K023694 (2003). 20 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 1.
- 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, Biopsy Sciences, LLC (2009) Summary page 1.

## Most influential descendants
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm (2016), 13 descendants of its own
- K163541: Magseed Magnetic Marker System (2017), 12 descendants of its own
- K210600: MOLLI (2021), 5 descendants of its own
- K223107: MOLLI 2 (2023), 4 descendants of its own
- K231579: MOLLI 2 (2023), 3 descendants of its own

## Indications for use
The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 30 days) mark a lumpectomy site intended for surgical removal. Using ultrasound or radiography imaging guidance, the Cianna Tissue Marker is located and surgically removed with the target tissue.

Source page: https://510kreport.com/device/K120804
Methodology: https://510kreport.com/methodology