THE ABLATION SYSTEM— 510(k) K121858

Substantially Equivalent

Halt Medical, Inc.

FDA 510(k) clearance K121858 for THE ABLATION SYSTEM, Substantially Equivalent on 2012-11-05. Applicant: Halt Medical, Inc..

Clearance details

Applicant: Halt Medical, Inc.
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 2012-06-26
Decision date: 2012-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brentwood, CA, US

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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.