PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X— 510(k) K910897
Substantially Equivalent3M Medical Products Group
FDA 510(k) clearance K910897 for PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X, Substantially Equivalent on 1991-04-01. Applicant: 3M Medical Products Group.
Clearance details
- Applicant
- 3M Medical Products Group
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Paul, MN, 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.