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

Brain Intraparenchymal Infusion Cannula

21 CFR 882.4110 / Neurology
FDA source (opens on fda.gov)

SDG is the FDA product code for Brain Intraparenchymal Infusion Cannula, a class II device type, regulated under 21 CFR 882.4110. FDA's definition for this code reads: "A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SDG
Device name
Brain Intraparenchymal Infusion Cannula
FDA definition
A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy.
Regulation
21 CFR 882.4110
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SDG

By decision year
1 clearance under product code SDG with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDG by decision year
YearClearances
20241

Applicants with the most clearances

Product code SDG
Applicants holding the most 510(k) clearances under product code SDG
ApplicantClearances
ClearPoint Neuro Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code