510(k) clearance

Microwave Ablation Antennas

FDA 510(k) source

510(k) number

K261636

Applicant

Canyon Medical, Inc.

Decision date

Oct 28, 2026

Date received

May 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NEY

Device type

System, Ablation, Microwave And Accessories

Device class

Class II

Regulation

21 CFR 878.4400

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Nanjing, CN