510(k) clearance

V-Pro maX 2 Low Temperature Sterilization System

FDA 510(k) source

510(k) number

K263530

Applicant

STERIS

Decision date

Oct 29, 2026

Date received

Sep 29, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

MLR

Device type

Sterilizer, Chemical

Device class

Class II

Regulation

21 CFR 880.6860

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

Mentor, OH, US