# K133148: Biomarc Coaxial Needle

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: May 13, 2014 after 208 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K820973 (1982). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042615: Carbon Medical Technologies Endoscopic Injection Needle, Carbon Medical Technologies, Inc. (2004) Summary page 1.
- K936194: Coaxial Biopsy Needle, Bard Gynecology and Radiology (1994) Summary page 1.

## Indications for use
The BiomnaiC Coaxial Needle allows delivery of fiducial markers into soft tissue.

Source page: https://510kreport.com/device/K133148
Methodology: https://510kreport.com/methodology