QC CAP— 510(k) K945567

Substantially Equivalent

Medionics International, Inc.

FDA 510(k) clearance K945567 for QC CAP, Substantially Equivalent on 1995-02-07. Applicant: Medionics International, Inc..

Clearance details

Applicant: Medionics International, Inc.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-27
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.