CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners— 510(k) K160900
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K160900 for CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners, Substantially Equivalent on 2016-05-31. Applicant: C.R. Bard, Inc..
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warwick, RI, 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.