# K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376

- Pathway: 510(k) (Traditional)
- Applicant: Mri Devices Corp.
- Decided: Jan 28, 2004 after 91 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). 6 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970817: Micromark Clip, Biopsys Medical, Inc. (1997) Summary page 1.
- K993785: Ultraclip Tissue Marker, Inrad (2000) Summary page 1.
- K013413: Micromark II Tissue Marker,Model C1535, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K020276: 8 Gauge Micromark II Tissue Marker, Models C1540 & C1535, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.
- K020054: Sanarus Indica Marker System, Sanarus Medical, Inc. (2002) Summary page 1.
- K000278: Vivant Medical Biopsy Marker System, Vivant Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm (2016), 13 descendants of its own

## Indications for use
The ClipLoc TM Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure. It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

Source page: https://510kreport.com/device/K033447
Methodology: https://510kreport.com/methodology