# K013413: Micromark II Tissue Marker,Model C1535

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 3, 2001 after 49 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
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 its predicate without a number.
- (no number) MicroMark™ Clip: named in the summary without a submission 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 MicroMark™ II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Source page: https://510kreport.com/device/K013413
Methodology: https://510kreport.com/methodology