CATHETER TUNNELER— 510(k) K972555

Substantially Equivalent

Gerard Medical, Inc.

FDA 510(k) clearance K972555 for CATHETER TUNNELER, Substantially Equivalent on 1997-12-22. Applicant: Gerard Medical, Inc..

Clearance details

Applicant: Gerard Medical, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1997-07-07
Decision date: 1997-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlton City, MA, 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.