Purevue™ FMS

The PUREVUE FMS is a fluid management system for arthroscopy. It supplies sterile irrigation fluid to distend the joint cavity and can remove fluid by suction, helping create working space…

Registry build 21.09.26

The PUREVUE FMS is a fluid management system for arthroscopy. It supplies sterile irrigation fluid to distend the joint cavity and can remove fluid by suction, helping create working space and maintain visibility during diagnostic or operative procedures.

Two independent peristaltic pumps control fluid movement through dedicated tube sets. Single roller mode provides inflow, while dual roller mode combines inflow and outflow. Software regulates the pump to maintain the selected joint pressure.

Joints and Setup

The system is intended for the knee, shoulder, hip, elbow, ankle and wrist. The pump remains in a nonsterile area and works with the appropriate irrigation and suction accessories, including tube sets, remote control and foot switch.

21manufacturers in China registered for this device type
1catalogue number
9510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRX
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Sanmina Kunshan Jiangsu Contract manufacturer 15
Peter’s Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Jiangsu Shenli Medical Production Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
PAN-International Precision Electronic Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26

Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope

Record

Regulatory record for Purevue™ FMS
Listed by W.O.M. World of Medicine GmbH, United States
FDA product code HRX
Device type Arthroscope
Device class Class 2
Regulation 21 CFR 888.1100
510(k) K250795
Record published 2026-03-10
Record revised 2026-03-27 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Purevue™ FMS
Catalogue number Size Status
PA124 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 299
Arthroscope Karl Storz GmbH & Co. KG 278
Conmed/Linvatec Provision 265
Arthroscope Smith & Nephew, Inc. 255
Medline Medline Industries, Inc. 205
Arthroscope Sterilmed, Inc. 184
Sustainable Technologies Provision 150
Medline Renewal Medline Industries, Inc. 123
Stryker Provision 113
Arthrex® Arthrex, Inc. 109
Arthrex Provision 109
Eberle Eberle GmbH & Co. KG 92

Showing 12 of 567. All products under Arthroscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K250795 2025-12-05
K173311 2018-05-09
K062380 2006-12-14
K033927 2004-01-15
K030402 2003-04-17
K000153 2000-02-08
K990443 1999-02-26
K983910 1998-11-25
K962114 1996-08-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer