ADVANCED UROSCIENCE INJECTION NEEDLE— 510(k) K982890

Name: FDA 510(k) clearance K982890
Creator: U.S. Food and Drug Administration
Published: 1998-10-26

Substantially Equivalent

Advanced Uroscience, Inc.

FDA 510(k) clearance K982890 for ADVANCED UROSCIENCE INJECTION NEEDLE, Substantially Equivalent on 1998-10-26. Applicant: Advanced Uroscience, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Uroscience, Inc.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1998-08-17
Decision date: 1998-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.