510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
SGNClass II

High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

21 CFR 882.4420 / Neurology
FDA source (opens on fda.gov)

SGN is the FDA product code for High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation, a class II device type, regulated under 21 CFR 882.4420. FDA's definition for this code reads: "A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SGN
Device name
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
FDA definition
A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling.
Regulation
21 CFR 882.4420
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 SGN

By decision year
1 clearance under product code SGN with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGN by decision year
YearClearances
20251

Applicants with the most clearances

Product code SGN
Applicants holding the most 510(k) clearances under product code SGN
ApplicantClearances
Fusmobile, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code