AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS— 510(k) K111810

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K111810 for AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS, Substantially Equivalent on 2011-09-02. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2011-06-27
Decision date: 2011-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

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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.