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FDA 510(k)

GYN-Pump PH304

K-Number: K173489 · 2018-03-28

ApplicantW.O.M. World of Medicine GmbH
Decision Date2018-03-28
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYN-Pump PH304 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-03-28 under 510(k) 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. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K173489.

When did GYN-Pump PH304 receive FDA 510(k) clearance?

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

Who is the listed applicant for GYN-Pump PH304?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing W.O.M. World of Medicine GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HIG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

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.

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