DeviceClearance

K201756

Substantially Equivalent

Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent

Applicant
Stryker Sustainability Solutions
Product code
HIH
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tempe, AZ, 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.