DeviceClearance

K802503

Substantially Equivalent

MICRO-SUGICAL POWER INSTRUMENT SYSTEM

Applicant
Spire Medical, Inc.
Product code
EQJ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ventura, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EQJ

product code EQJ
Malfunction
1,552
Total
1,552

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.