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FDA 510(k)

IUR FLUID MANAGEMENT SYSTEM

K-Number: K031616 · 2003-08-13

ApplicantW.O.M. World of Medicine AG
Decision Date2003-08-13
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IUR FLUID MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine AG. It received FDA 510(k) clearance on 2003-08-13 under 510(k) number K031616. 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 IUR FLUID MANAGEMENT SYSTEM?

IUR FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-13. The listed applicant is W.O.M. World of Medicine AG. The 510(k) number is K031616.

When did IUR FLUID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

IUR FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 2003-08-13, under 510(k) number K031616.

Who is the listed applicant for IUR FLUID MANAGEMENT SYSTEM?

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

What is the FDA product code for IUR FLUID MANAGEMENT SYSTEM?

The FDA product code for IUR FLUID MANAGEMENT SYSTEM is HIG.

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Other records listing W.O.M. World of Medicine AG 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.

K123732HYSTEROSCOPY PUMP HM6K112642AQUILEX FLUID CONTROL SYSTEM H112K06336745L CORE INSUFFLATOR, MODEL F114K062380FLOSIMPLE ARTHROSCOPY PUMP A120K06072340 L HIGH FLOW INSUFFLATOR F113K042457URO PRO

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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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