KALTOSTAT(TM) WOUND DRESSING— 510(k) K892364

Substantially Equivalent

Calgon Vestal Div.

FDA 510(k) clearance K892364 for KALTOSTAT(TM) WOUND DRESSING, Substantially Equivalent on 1989-06-23. Applicant: Calgon Vestal Div..

Clearance details

Applicant: Calgon Vestal Div.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1989-04-06
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.