FRANKENMAN SURGICAL STAPLERS— 510(k) K101378
Substantially EquivalentSuzhou Frankenman Medical Equipment Co., Ltd.
FDA 510(k) clearance K101378 for FRANKENMAN SURGICAL STAPLERS, Substantially Equivalent on 2010-06-29. Applicant: Suzhou Frankenman Medical Equipment Co., Ltd..
Clearance details
- Applicant
- Suzhou Frankenman Medical Equipment Co., Ltd.
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, 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.