FDA 510(k) clearance · back to tracker

Certus 140 2.45GHz Ablation System

Neuwave Medical, Inc. cleared K173756 on 2018-10-24, decision: substantially equivalent

K-number

K173756

Sponsor

Neuwave Medical, Inc.

Device

Certus 140 2.45GHz Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2018-10-24

Product code

NEY

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K173756on 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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Raw record →

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

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Source

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