DeviceClearance

K911262

Substantially Equivalent

DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER

Applicant
ETHICON, Inc.
Product code
GEA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Somerville, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GEA

product code GEA
Malfunction
587
Total
587

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.