CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control— 510(k) K182882
Substantially EquivalentConmed Corporation
FDA 510(k) clearance K182882 for CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control, Substantially Equivalent on 2018-11-14. Applicant: Conmed Corporation.
Clearance details
- Applicant
- Conmed Corporation
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Utica, NY, US
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.