FDA 510(k) clearance · back to tracker

Certus 140 2.45GHz Ablation System

Neuwave Medical, Inc. cleared K160936 on 2016-05-04, decision: substantially equivalent

K-number

K160936

Sponsor

Neuwave Medical, Inc.

Device

Certus 140 2.45GHz Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2016-05-04

Product code

NEY

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K160936on 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 K160936 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.