GERITREX STERILE SALINE SOLUTION FOR IRRIGATION— 510(k) K931509

Substantially Equivalent

Geritrex Corp.

FDA 510(k) clearance K931509 for GERITREX STERILE SALINE SOLUTION FOR IRRIGATION, Substantially Equivalent on 1994-09-22. Applicant: Geritrex Corp..

Clearance details

Applicant: Geritrex Corp.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1993-03-26
Decision date: 1994-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Vernon, NY, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.