INTEGRATED VISUALIZATION SYSTEM— 510(k) K970598

Name: FDA 510(k) clearance K970598
Creator: U.S. Food and Drug Administration
Published: 1997-03-12

Substantially Equivalent

Urohealth, Inc.

FDA 510(k) clearance K970598 for INTEGRATED VISUALIZATION SYSTEM, Substantially Equivalent on 1997-03-12. Applicant: Urohealth, Inc.. Device class: 2.

Clearance details

Applicant: Urohealth, Inc.
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-18
Decision date: 1997-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.