What is the POWERPUMP ARTHROSCOPY SYSTEM used for?

The POWERPUMP ARTHROSCOPY SYSTEM is designed to provide fluid management during arthroscopic procedures, specifically in orthopedic surgery, to maintain clear visualization and irrigation control.

Is the POWERPUMP ARTHROSCOPY SYSTEM reusable or single-use?

The system is supplied as a reusable device, meaning it is intended for multiple uses after proper cleaning and reprocessing in accordance with the manufacturer's instructions for clinical settings.

What regulatory pathway was used for the POWERPUMP ARTHROSCOPY SYSTEM?

The device received FDA 510(k) clearance under product code HRX, demonstrating substantial equivalence to a predicate device through a traditional review process.

Powerpump Arthroscopy System

by Medical Vision AB

510(k) K093409

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K093409↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK093409	Date24 Feb 2010Cleared	StatusActive

Recalls

1 recall · FDA

- Terminated Z-2705-2016 FDA Class II initiated 10 May 2016
Sterility of device may be compromised due to sterile package breakage.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K093409
FDA Product Code: HRX

Device Class: Class II
Regulation: 21 CFR Part 888.1100
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The POWERPUMP ARTHROSCOPY SYSTEM is a device used in arthroscopic procedures. It is designed to provide fluid management during orthopedic surgery.

The system is supplied as a reusable device and is intended for use in clinical settings. It has received FDA 510(k) clearance under product code HRX and was found substantially equivalent to a predicate device. The device is manufactured by Medical Vision AB and is not MRI conditional unless explicitly stated in the specifications.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

What is the POWERPUMP ARTHROSCOPY SYSTEM used for?

The POWERPUMP ARTHROSCOPY SYSTEM is designed to provide fluid management during arthroscopic procedures, specifically in orthopedic surgery, to maintain clear visualization and irrigation control.
Is the POWERPUMP ARTHROSCOPY SYSTEM reusable or single-use?

The system is supplied as a reusable device, meaning it is intended for multiple uses after proper cleaning and reprocessing in accordance with the manufacturer's instructions for clinical settings.
What regulatory pathway was used for the POWERPUMP ARTHROSCOPY SYSTEM?

The device received FDA 510(k) clearance under product code HRX, demonstrating substantial equivalence to a predicate device through a traditional review process.