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FMS VUE™ Fluid Management and Tissue Debridement System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233675

by DePuy Mitek, Inc.

Identifiers

510(k) Number
K233675 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

FMS VUE™ Fluid Management and Tissue Debridement System by DePuy Mitek, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
DePuy Mitek, Inc.

Sources (1)

  • FDA 510(k) K233675 24 fields · synced Jun 18, 2026