Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft— 510(k) K160869
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K160869 for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft, Substantially Equivalent on 2016-04-29. Applicant: Cook Biotech Incorporated.
Clearance details
- Applicant
- Cook Biotech Incorporated
- Product code
- Code FTM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Lafayette, IN, US
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.