510(k) · Cleared
ClearedClarus Endoscopic Discectomy System Sitetrac Model 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical Systems, Inc. · GAD Retractor
Cleared on Aug 18, 1998 after a 182-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 18, 1998
- Review
- 182 days
- Class
- Class I
- Product code
- GAD
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Sofamor Danek MED MicroEndoscopic Discectomy System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GAD devicesGAD Retractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAD
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GAD
Too few GAD 510(k)s in any year since 2007 to give a median.
Recalls per year · GAD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAD
107in 2025
MAUDE reports naming product code GAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 38 |
| 2008 | 0 | — | 1 | 45 |
| 2009 | 0 | — | 1 | 64 |
| 2010 | 0 | — | 0 | 52 |
| 2011 | 0 | — | 0 | 50 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 3 | 88 |
| 2014 | 0 | — | 2 | 80 |
| 2015 | 0 | — | 1 | 67 |
| 2016 | 2 | — | 0 | 78 |
| 2017 | 0 | — | 0 | 90 |
| 2018 | 0 | — | 0 | 77 |
| 2019 | 0 | — | 0 | 62 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 80 |
| 2024 | 0 | — | 1 | 111 |
| 2025 | 0 | — | 0 | 107 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980588 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980588: Clarus Endoscopic Discectomy System Sitetrac Model 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980588
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026