CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400— 510(k) K991529
Substantially EquivalentConway Stuart Medical, Inc.
FDA 510(k) clearance K991529 for CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400, Substantially Equivalent on 1999-09-14. Applicant: Conway Stuart Medical, Inc..
Clearance details
- Applicant
- Conway Stuart Medical, Inc.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, 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.