510(k) K222093— V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

Substantially Equivalent

Steris

Clearance details

Applicant: Steris
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2022-07-15
Decision date: 2022-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Adverse events under product code MLR

product code MLR

Malfunction: 805
Total: 805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.