CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER— 510(k) K980109

Name: FDA 510(k) clearance K980109
Creator: U.S. Food and Drug Administration
Published: 1998-08-18

Substantially Equivalent

Sangstat Medical Corp.

FDA 510(k) clearance K980109 for CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER, Substantially Equivalent on 1998-08-18. Applicant: Sangstat Medical Corp.. Device class: 1.

Clearance details

Applicant: Sangstat Medical Corp.
Product code: Code KYX
Device class: Class 1
Regulation: 21 CFR 880.6430
Advisory panel: General Hospital
Date received: 1998-01-12
Decision date: 1998-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KYX

product code KYX

Death: 3
Other: 8
Total: 11

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.