OMNIPICC PI— 510(k) K051102

Substantially Equivalent

Rita Medical Systems, Inc.

FDA 510(k) clearance K051102 for OMNIPICC PI, Substantially Equivalent on 2005-11-23. Applicant: Rita Medical Systems, Inc..

Clearance details

Applicant: Rita Medical Systems, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2005-04-29
Decision date: 2005-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.