# K042615: Carbon Medical Technologies Endoscopic Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Nov 5, 2004 after 42 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: 3 generations back to K820973 (1982). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955558: Gip/Medi-Globe Sclerotherapy Needles, Medi-Globe Corp. (1996) Summary page 1.
- K982890: Advanced Uroscience Injection Needle, Advanced Uroscience, Inc. (1998) Summary page 1.

## Most influential descendants
- K172227: Endoscopic Injection Needle (2017), 0 descendants of its own
- K133148: Biomarc Coaxial Needle (2014), 0 descendants of its own

## Indications for use
The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure

Source page: https://510kreport.com/device/K042615
Methodology: https://510kreport.com/methodology