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FDA 510(k)

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

K-Number: K182568 · 2019-01-03

ApplicantSTERIS Corporation
Decision Date2019-01-03
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K182568. 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 s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System?

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is STERIS Corporation. The 510(k) number is K182568.

When did V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System receive FDA 510(k) clearance?

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System received FDA 510(k) clearance on 2019-01-03, under 510(k) number K182568.

Who is the listed applicant for V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System?

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 s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System?

The FDA product code for V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System is MLR.

Other records listing STERIS Corporation as applicant

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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.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization ProductsK233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris

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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