# K032390: Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Aug 29, 2003 after 25 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) EBI TargetCath Fluoro-Guided Steerable Catheter: named in the summary without a submission number

## Most influential descendants
- K150789: Spinaut-E, Spinaut-I (2016), 1 descendant of its own
- K241410: EDEN ControlCath (2025), 0 descendants of its own

## Indications for use
When used with a fluoroscope, the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System can be used in the lumbar and sacral spine for delivery of drugs approved for epidural indications. The System may also be used for the purpose of assisting in the diagnosis and treatment of disease utilizing a caudal approach via the sacral hiatus.

Source page: https://510kreport.com/device/K032390
Methodology: https://510kreport.com/methodology