KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM)— 510(k) K971790

Substantially Equivalent

Urometrics, Inc.

FDA 510(k) clearance K971790 for KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM), Substantially Equivalent on 1997-12-17. Applicant: Urometrics, Inc..

Clearance details

Applicant: Urometrics, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1997-05-14
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.