AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY— 510(k) K093410
Substantially EquivalentSurgical Devices, A Divsion of Tyco Healthcare
FDA 510(k) clearance K093410 for AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY, Substantially Equivalent on 2009-11-12. Applicant: Surgical Devices, A Divsion of Tyco Healthcare.
Clearance details
- Applicant
- Surgical Devices, A Divsion of Tyco Healthcare
- 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.