FDA 510(k) clearance · back to tracker

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

Relievant Medsystems cleared K190504 on 2019-05-03, decision: substantially equivalent

K-number

K190504

Sponsor

Relievant Medsystems

Device

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

Class

Class II

Decision

Substantially Equivalent

Decision date

2019-05-03

Product code

GXI

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4725

Official FDA record

Open K190504on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.