PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE— 510(k) K083415
Substantially EquivalentPeak Surgical, Inc.
FDA 510(k) clearance K083415 for PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE, Substantially Equivalent on 2009-06-05. Applicant: Peak Surgical, Inc..
Clearance details
- Applicant
- Peak Surgical, Inc.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, 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.