High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

SGN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4420

Classification

FDA Product Code: SGN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4420
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown