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FDA 510(k)

FMS VUE II Fluid Management and Tissue Debridement System

K-Number: K171237 · 2018-01-18

ApplicantMedos International SARL
Decision Date2018-01-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FMS VUE II Fluid Management and Tissue Debridement System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K171237. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FMS VUE II Fluid Management and Tissue Debridement System?

FMS VUE II Fluid Management and Tissue Debridement System is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Medos International SARL. The 510(k) number is K171237.

When did FMS VUE II Fluid Management and Tissue Debridement System receive FDA 510(k) clearance?

FMS VUE II Fluid Management and Tissue Debridement System received FDA 510(k) clearance on 2018-01-18, under 510(k) number K171237.

Who is the listed applicant for FMS VUE II Fluid Management and Tissue Debridement System?

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

What is the FDA product code for FMS VUE II Fluid Management and Tissue Debridement System?

The FDA product code for FMS VUE II Fluid Management and Tissue Debridement System is HRX.

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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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