DeviceClearance

K083839

Substantially Equivalent

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

Applicant
C.R. Bard, Inc.
Product code
OTP
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Covington, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTP

product code OTP
Injury
1,061
Total
1,061

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.