# K982484: Ebi Vuecath Endoscopic Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Oct 8, 1998 after 83 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 Spinal Endoscopic System: named in the summary without a submission number
- (no number) Myelotec Myeloscope System: 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
The EBI VueCath™ Spinal Endoscopic System is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.

Source page: https://510kreport.com/device/K982484
Methodology: https://510kreport.com/methodology