HUGH YOUNG II UROLOGICAL X-RAY SYSTEM— 510(k) K904147

Substantially Equivalent

Mallinckrodt Group, Inc.

FDA 510(k) clearance K904147 for HUGH YOUNG II UROLOGICAL X-RAY SYSTEM, Substantially Equivalent on 1990-12-13. Applicant: Mallinckrodt Group, Inc..

Clearance details

Applicant: Mallinckrodt Group, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1990-09-07
Decision date: 1990-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.