FDA 510(k)

GYN-Pump PH304

K-Number: K173489 · 2018-03-28

Decision Date2018-03-28

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GYN-Pump PH304 is a medical device manufactured by W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-03-28 under approval number K173489. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYN-Pump PH304?

GYN-Pump PH304 is a medical device that received FDA 510(k) clearance on 2018-03-28. It is manufactured by W.O.M. World of Medicine GmbH. The 510(k) number is K173489.

When was GYN-Pump PH304 approved by the FDA?

GYN-Pump PH304 received FDA 510(k) clearance on 2018-03-28, under approval number K173489.

What company makes GYN-Pump PH304?

GYN-Pump PH304 is manufactured by W.O.M. World of Medicine GmbH.

What is the FDA product code for GYN-Pump PH304?

The FDA product code for GYN-Pump PH304 is HIG.

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

K153513Insufflator 50L FM134 K170784PNEUMOCLEAR K163320LAP-Pump PP110 K173311ARTHRO-Pump PA304 K172040Aquilex Fluid Control System AQL-100S K201361PNEUMOCLEAR

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Related Devices (Code: HIG)

K172048FluidSmartThermedx, LLC K180735Endomat SelectKarl Storz SE & CO. KG K180825Fluent Fluid Management SystemHologic, Inc. K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG K210628X-FLO Fluid Management SystemThermedx, LLC

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.