ACESSA GUIDANCE HANDPIECE— 510(k) K132184

Substantially Equivalent

Halt Medical, Inc.

FDA 510(k) clearance K132184 for ACESSA GUIDANCE HANDPIECE, Substantially Equivalent on 2014-04-28. Applicant: Halt Medical, Inc..

Clearance details

Applicant: Halt Medical, Inc.
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 2013-07-15
Decision date: 2014-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brentwood, CA, 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.