GUARDPORT— 510(k) K921478

Substantially Equivalent

Health Improvement Assoc.

FDA 510(k) clearance K921478 for GUARDPORT, Substantially Equivalent on 1995-01-11. Applicant: Health Improvement Assoc..

Clearance details

Applicant: Health Improvement Assoc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-30
Decision date: 1995-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeland, MI, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.