V-PRO maX 2 Low Temperature Sterilization System— 510(k) K233065

Substantially Equivalent

Steris

FDA 510(k) clearance K233065 for V-PRO maX 2 Low Temperature Sterilization System, Substantially Equivalent on 2023-10-20. Applicant: Steris.

Clearance details

Applicant: Steris
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2023-09-26
Decision date: 2023-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, MA, US

Download summary PDF View on FDA.gov ↗

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.