K142808

Substantially Equivalent

CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners

Applicant: C.R. Bard, Inc.
Product code: GDW
Advisory panel: General, Plastic Surgery
Date received: 2014-09-29
Decision date: 2015-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.