# K982819: Endius Spine Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Jan 27, 1999 after 169 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Endius Spine Endoscope is indicated for aiding in the search and removal of nucleus material and for visualization of lumbar herniated discs. It is intended to be used percutaneously in the lumbar spine. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist, and the temporomandibular joint (TMJ).

Source page: https://510kreport.com/device/K982819
Methodology: https://510kreport.com/methodology