POWERSEAL Curved Jaw Sealer and Divider, Double Action— 510(k) K212643
Substantially EquivalentOlympus Surgical Technologies America
FDA 510(k) clearance K212643 for POWERSEAL Curved Jaw Sealer and Divider, Double Action, Substantially Equivalent on 2021-09-27. Applicant: Olympus Surgical Technologies America.
Clearance details
- Applicant
- Olympus Surgical Technologies America
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brooklyn Park, MN, 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.