CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L— 510(k) K090821
Substantially EquivalentFrankenman International Limited
FDA 510(k) clearance K090821 for CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L, Substantially Equivalent on 2009-06-10. Applicant: Frankenman International Limited.
Clearance details
- Applicant
- Frankenman International Limited
- 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.