FDA 510(k)

ARTHRO-Pump PA304

K-Number: K173311 · 2018-05-09

Decision Date2018-05-09

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ARTHRO-Pump PA304 is a medical device manufactured by W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-05-09 under approval number K173311. 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 ARTHRO-Pump PA304?

ARTHRO-Pump PA304 is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by W.O.M. World of Medicine GmbH. The 510(k) number is K173311.

When was ARTHRO-Pump PA304 approved by the FDA?

ARTHRO-Pump PA304 received FDA 510(k) clearance on 2018-05-09, under approval number K173311.

What company makes ARTHRO-Pump PA304?

ARTHRO-Pump PA304 is manufactured by W.O.M. World of Medicine GmbH.

What is the FDA product code for ARTHRO-Pump PA304?

The FDA product code for ARTHRO-Pump PA304 is HRX.

Other Devices by W.O.M. World of Medicine GmbH

K153513Insufflator 50L FM134 K170784PNEUMOCLEAR K163320LAP-Pump PP110 K173489GYN-Pump PH304 K172040Aquilex Fluid Control System AQL-100S K201361PNEUMOCLEAR

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Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

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.