VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula— 510(k) K213818

Substantially Equivalent

Covidien

FDA 510(k) clearance K213818 for VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula, Substantially Equivalent on 2022-06-27. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-07
Decision date: 2022-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, 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, 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.