PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES— 510(k) K062072
Substantially EquivalentPAJUNK GmbH Medizintechnologie
FDA 510(k) clearance K062072 for PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES, Substantially Equivalent on 2006-09-22. Applicant: PAJUNK GmbH Medizintechnologie.
Clearance details
- Applicant
- PAJUNK GmbH Medizintechnologie
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Geisingen, DE
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.