510(k) clearance

Arctic Sun™ Neonatal ArcticGel™ Pad

FDA 510(k) source

510(k) number

K263587

Applicant

Medivance, Inc.

Decision date

Oct 30, 2026

Date received

Sep 30, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

DWJ

Device type

System, Thermal Regulating

Device class

Class II

Regulation

21 CFR 870.5900

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Louisville, CO, US