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FDA 510(k)

V-PRO® 1 Plus and V-PRO® maX Low Temperature

K-Number: K160433 · 2016-07-06

ApplicantSTERIS Corporation
Decision Date2016-07-06
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-PRO® 1 Plus and V-PRO® maX Low Temperature is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K160433. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-PRO® 1 Plus and V-PRO® maX Low Temperature?

V-PRO® 1 Plus and V-PRO® maX Low Temperature is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is STERIS Corporation. The 510(k) number is K160433.

When did V-PRO® 1 Plus and V-PRO® maX Low Temperature receive FDA 510(k) clearance?

V-PRO® 1 Plus and V-PRO® maX Low Temperature received FDA 510(k) clearance on 2016-07-06, under 510(k) number K160433.

Who is the listed applicant for V-PRO® 1 Plus and V-PRO® maX Low Temperature?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V-PRO® 1 Plus and V-PRO® maX Low Temperature?

The FDA product code for V-PRO® 1 Plus and V-PRO® maX Low Temperature is MLR.

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Related Devices (Code: MLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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