AMCATH COAGULATION PROBE— 510(k) K902555

Substantially Equivalent

Intl. Medical, Inc.

FDA 510(k) clearance K902555 for AMCATH COAGULATION PROBE, Substantially Equivalent on 1990-06-20. Applicant: Intl. Medical, Inc..

Clearance details

Applicant: Intl. Medical, Inc.
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 1990-06-08
Decision date: 1990-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danielson, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HFG

product code HFG

Death: 3
Injury: 121
Total: 124

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.