510(k) clearance

Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)

FDA 510(k) source

510(k) number

K262420

Applicant

Serpex Medical

Decision date

Sep 2, 2026

Date received

Jul 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GEH

Device type

Unit, Cryosurgical, Accessories

Device class

Class II

Regulation

21 CFR 878.4350

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Santa Clara, CA, US