# K980588: Clarus Endoscopic Discectomy System Sitetrac Model 6000

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical Systems, Inc.
- Decided: Aug 18, 1998 after 182 days
- Product code: GAD (Retractor)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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) Sofamor Danek MED MicroEndoscopic Discectomy System: named in the summary without a submission number

## Indications for use
The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

Source page: https://510kreport.com/device/K980588
Methodology: https://510kreport.com/methodology