# K990459: Ebi Vuecath Endoscopic Systen

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Apr 23, 1999 after 70 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- 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

## Indications for use
When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications. In addition, the system may 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/K990459
Methodology: https://510kreport.com/methodology