510(k) K904216— STERILE WATER SOLUTION CATALOG # 10000

Substantially Equivalent

Superior Healthcare Group, Inc.

Clearance details

Applicant: Superior Healthcare Group, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1990-09-12
Decision date: 1990-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland, RI, 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.