Electrosurgical accessory— 510(k) K210394
Substantially EquivalentDornier Medtech America, Inc.
FDA 510(k) clearance K210394 for Electrosurgical accessory, Substantially Equivalent on 2021-05-19. Applicant: Dornier Medtech America, Inc..
Clearance details
- Applicant
- Dornier Medtech America, Inc.
- Product code
- Code FAS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennesaw, GA, US
Adverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
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.