DeviceClearance

K011257

Substantially Equivalent

ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)

Applicant
Ethicon Endo-Surgery, Inc.
Product code
GCJ
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cincinnati, OH, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ
Death
39
Injury
1,638
Malfunction
28,216
Other
11
Total
29,904

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.