CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000— 510(k) K980588
Substantially EquivalentClarus Medical Systems, Inc.
FDA 510(k) clearance K980588 for CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000, Substantially Equivalent on 1998-08-18. Applicant: Clarus Medical Systems, Inc..
Clearance details
- Applicant
- Clarus Medical Systems, Inc.
- Product code
- Code GAD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code GAD
product code GAD- Malfunction
- 504
- Total
- 504
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.