AMSCO V-PRO— 510(k) K112813

Substantially Equivalent

Steris Corp

FDA 510(k) clearance K112813 for AMSCO V-PRO, Substantially Equivalent on 2011-12-01. Applicant: Steris Corp.

Clearance details

Applicant: Steris Corp
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2011-09-27
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Special
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.