FDA 510(k) clearance · back to tracker

Intracept Intraosseous Nerve Ablation System

Relievant Medsystems, Inc. cleared K222281 on 2022-10-26, decision: substantially equivalent

K-number

K222281

Sponsor

Relievant Medsystems, Inc.

Device

Intracept Intraosseous Nerve Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2022-10-26

Product code

GXI

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4725

Official FDA record

Open K222281on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K222281 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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