Cleared Traditional

FMS VUE? Fluid Management and Tissue Debridement System

K233675 · DePuy Mitek, Inc. · Orthopedic

Feb 2024

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K233675 is an FDA 510(k) clearance for the FMS VUE? Fluid Management and Tissue Debridement System, a Arthroscope (Class II — Special Controls, product code HRX), submitted by DePuy Mitek, Inc. (Raynham, US). The FDA issued a Cleared decision on February 26, 2024, 102 days after receiving the submission on November 16, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K233675 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2023
Decision Date	February 26, 2024
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).