510(k) K000265— PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

Substantially Equivalent

Primary Care Solutions, Inc.

Clearance details

Applicant: Primary Care Solutions, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 2000-01-28
Decision date: 2001-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringwood, NJ, US

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.