Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable— 510(k) K182801
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K182801 for Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable, Substantially Equivalent on 2018-11-27. Applicant: Integra LifeSciences Corporation.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.