MYOSURE CONTROL UNIT— 510(k) K120593

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K120593 for MYOSURE CONTROL UNIT, Substantially Equivalent on 2012-03-23. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2012-02-28
Decision date: 2012-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Malborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.