DeviceClearance

K913987

Substantially Equivalent

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID

Applicant
Codman & Shurtleff, Inc.
Product code
ITY
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Randolph, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code ITY

product code ITY
Other
1
Total
1

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.