STERILE WATER— 510(k) K933526

Substantially Equivalent

Trinity Laboratories, Inc.

FDA 510(k) clearance K933526 for STERILE WATER, Substantially Equivalent on 1994-03-10. Applicant: Trinity Laboratories, Inc..

Clearance details

Applicant: Trinity Laboratories, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1993-07-21
Decision date: 1994-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salisbury, MD, 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.