SureTune4 Software
Summary
Medtronic Neuromodulation received 510(k) clearance for SureTune4 Software, a QQC device. Cleared on 2021-08-23.
Details
Source
510(k) Clearance
External ID
DEN210003
Action Date
2021-08-23
Status
Direct
Category
device
Product Code
QQC
Product Description
SureTune4 Software. Product code: QQC.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN210003" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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