BIOKNOTLESS ANCHOR— 510(k) K002639
Substantially EquivalentMitek Products
FDA 510(k) clearance K002639 for BIOKNOTLESS ANCHOR, Substantially Equivalent on 2001-05-11. Applicant: Mitek Products.
Clearance details
- Applicant
- Mitek Products
- Product code
- Code GAM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwood, MA, US
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.