# K020054: Sanarus Indica Marker System

- Pathway: 510(k) (Traditional)
- Applicant: Sanarus Medical, Inc.
- Decided: Oct 16, 2002 after 281 days
- Product code: FZP (Clip, 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
No predicates in its family tree.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376 (2004), 25 descendants of its own
- K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560 (2008), 23 descendants of its own
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 (2010), 21 descendants of its own
- K111692: Tumark Flex for Mammotome,Tumark Flex for Atec (2011), 16 descendants of its own
- K120804: Cianna Medical Tissue Marker and Delivery System (2013), 15 descendants of its own

## Indications for use
The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.

Source page: https://510kreport.com/device/K020054
Methodology: https://510kreport.com/methodology