# K141318: Cianna Medical SGS System

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical, Inc.
- Decided: Aug 27, 2014 after 99 days
- Product code: PDW (Internal Tissue Marker)
- Device class: 2
- Regulation: 21 CFR 878.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 7 days) mark a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (SGS System) the SGS Tissue Marker is located and surgically removed with the target tissue. The SGS System is intended only for the non-imaging detection and localization of the “SGS Marker” that has been implanted in a lumpectomy site intended for surgical removal.

Source page: https://510kreport.com/device/K141318
Methodology: https://510kreport.com/methodology