V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System— 510(k) K182568

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K182568 for V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, Substantially Equivalent on 2019-01-03. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2018-09-18
Decision date: 2019-01-03
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.