# K030451: Carbon Medical Technologies Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Apr 30, 2003 after 78 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: 1 generation back to K843719 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002323: Advanced Uroscience Injection Needle, Advanced Uroscience, Inc. (2000) Summary page 1.
- K843719: Single Wall Introducer Needle, Ocean Medical Products, Ltd. (1984)

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

Source page: https://510kreport.com/device/K030451
Methodology: https://510kreport.com/methodology