DeviceClearance

K152723

Substantially Equivalent

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

Applicant
Hologic, Inc.
Product code
HIH
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
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, through . 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.