Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil— 510(k) K200372
Substantially EquivalentModern Medical Equipment Manufacturing, Ltd.
FDA 510(k) clearance K200372 for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil, Substantially Equivalent on 2020-11-30. Applicant: Modern Medical Equipment Manufacturing, Ltd..
Clearance details
- Applicant
- Modern Medical Equipment Manufacturing, Ltd.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hong Kong, CN
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.