HysteroLux™ Fluid Management System Control Unit

FDA UDI

Class II (US FDA UDI)

by W.O.M. World of Medicine GmbH

Identity

Trade Name: HysteroLux™ Fluid Management System Control Unit FDA UDI
Generic Name: Hysteroscopic irrigation/insufflation system FDA UDI
Model / Reference: PH304 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056702005672 FDA UDI
510(k) Number: K173489 FDA UDI
FDA Product Code: HIG FDA UDI
GMDN Term: Hysteroscopic irrigation/insufflation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hysteroscopic irrigation/insufflation system

HysteroLux™ Fluid Management System Control Unit by W.O.M. World of Medicine GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hysteroscopic irrigation/insufflation system.

Hayden Medical — Hayden Medical Inc · Class II
Fluid Safe — Stryker Corp. · Class II
TRUCLEARTM Calibration Insert 2.9 — Smith & Nephew, Inc. · Class II
Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
TruClear — Covidien LP · Class II
Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
ThermaClear — Stryker Corp. · Class II
Luer Lock Set, Single Lumen — Thermedx, LLC · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: W.O.M. World of Medicine GmbH

Sources (1)

FDA UDI 74c9879c-011c-48e5-b04b-ecb9131691e8 33 fields · synced May 30, 2026