# K032217: 14G Cormark Biopsy Site Identifier

- Pathway: 510(k) (Special)
- Applicant: Artemis Medical, Inc.
- Decided: Aug 21, 2003 after 31 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.
9 later devices descend from it; 1 cites it directly.
2 of 10 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) Caris Site Marker: named in the summary without a submission number

## Most influential descendants
- K113202: Tissue Marker (2012), 8 descendants of its own
- K143484: BioZorb Marker (2015), 7 descendants of its own
- K152070: BioZorb LP Marker (2015), 5 descendants of its own
- K180640: SmartClip Soft Tissue Marker (2018), 1 descendant of its own
- K233639: SmartClip Secure Soft Tissue Marker (2024), 0 descendants of its own

## Indications for use
The 14G CoRMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.

Source page: https://510kreport.com/device/K032217
Methodology: https://510kreport.com/methodology