Cleared Special

IUR FLUID MANAGEMENT SYSTEM (K031616) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031616 · W.O.M. World of Medicine AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
82d
Days
Class 2
Risk

K031616 is an FDA 510(k) clearance for the IUR FLUID MANAGEMENT SYSTEM. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by W.O.M. World of Medicine AG (Alexandria, US). The FDA issued a Cleared decision on August 13, 2003 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all W.O.M. World of Medicine AG devices

Submission Details

510(k) Number K031616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2003
Decision Date August 13, 2003
Days to Decision 82 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 160d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 16
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K031616.
Fluent Fluid Management System
K180825 · Hologic, Inc. · Aug 2018
GYN-Pump PH304
K173489 · W.O.M. World of Medicine GmbH · Mar 2018
Aquilex Fluid Control System AQL-100S
K172040 · W.O.M. World of Medicine GmbH · Feb 2018
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
HYSTERO CO2-PNEU 2221
K964136 · Richard Wolf Medical Instruments Corp. · Jan 1997
KARL STORZ MODEL 203020 20 EQUIMAT
K961091 · KARL STORZ Endoscopy-America, Inc. · Oct 1996