QUICK CHANGE MONTGOMERY STRAP— 510(k) K893569

Substantially Equivalent

Med-Dex Intl.

FDA 510(k) clearance K893569 for QUICK CHANGE MONTGOMERY STRAP, Substantially Equivalent on 1989-09-25. Applicant: Med-Dex Intl..

Clearance details

Applicant: Med-Dex Intl.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1989-05-09
Decision date: 1989-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.