LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120— 510(k) K040424
Substantially EquivalentClarus Medical, LLC
FDA 510(k) clearance K040424 for LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120, Substantially Equivalent on 2004-05-11. Applicant: Clarus Medical, LLC.
Clearance details
- Applicant
- Clarus Medical, LLC
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.