K112349

Substantially Equivalent

VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR

Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
Product code: GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2011-08-16
Decision date: 2011-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: North Haven, CT, US

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, 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.