V-PRO® 1 Plus and V-PRO® maX Low Temperature— 510(k) K160433

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K160433 for V-PRO® 1 Plus and V-PRO® maX Low Temperature, Substantially Equivalent on 2016-07-06. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2016-02-16
Decision date: 2016-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.