# K023233: Ebi Targetcath Fluoro-Guided Steerable Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Dec 13, 2002 after 77 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 VueCath Spinal Endoscopic System: named in the summary without a submission number
- (no number) Myelotec Video Guided Catheter: named in the summary without a submission number
- (no number) Myelotec Myeloscope System: named in the summary without a submission number
- (no number) Myelotec NaviCath Steerable Catheter: named in the summary without a submission number
- (no number) NaviCath Steerable Catheter: named in the summary without a submission number
- (no number) NaviCath Steerable Catheter: named in the summary without a submission number

## Recalls of this device
- Jun 17, 2003 · Not classified · Z-1006-03: Non sterile device is labeled sterile.

## Indications for use
When used with a fluoroscope, the EBI@ TargetCathm 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/K023233
Methodology: https://510kreport.com/methodology