ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE— 510(k) K091900
Substantially EquivalentCovidien Lp, Formerly Registered AS United States
FDA 510(k) clearance K091900 for ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE, Substantially Equivalent on 2009-07-16. Applicant: Covidien Lp, Formerly Registered AS United States.
Clearance details
- Applicant
- Covidien Lp, Formerly Registered AS United States
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Haven, CT, US
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.