510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210003Unknown

SureTune4 Software

Medtronic Neuromodulation, Minneapolis MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN210003 is the FDA 510(k) clearance record for SureTune4 Software, a class II device, cleared for Medtronic Neuromodulation on under FDA product code QQC (Brain Stimulation Programming Planning Software.). FDA's definition for product code QQC reads: "The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators". FDA records list 3 510(k) clearances for Medtronic Neuromodulation, from to . As of , FDA records show no recalls naming DEN210003.

Clearance record

Decision date
Received
(201 days to decision)
Product code
QQC Brain Stimulation Programming Planning Software.
Regulation
21 CFR 882.5855
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Neuromodulation 7000 Central Ave., NE, Minneapolis MN
Third party review
No

Clearances, product code QQC

Trailing 12 months

FDA records hold no clearances under product code QQC in the trailing twelve months.

FDA records show no clearances under product code QQC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260