QQC — Brain Stimulation Programming Planning Software. Class II

FDA Device Classification

FDA product code QQC covers "Brain Stimulation Programming Planning Software.", a Class II medical device regulated under 21 CFR 882.5855. Submissions are reviewed by the Neurology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
QQC
Device Class
Class II
Regulation Number
882.5855
Submission Type
510(k)
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K243520Turing Medical TechnologiesBullsai ConfirmMar 28, 2025
K213930BrainlabBrainlab Elements Guide XT, Guide 3.0Apr 19, 2022
DEN210003Medtronic NeuromodulationSureTune4 SoftwareAug 23, 2021

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.