Cleared Special

K123732 - HYSTEROSCOPY PUMP HM6

K123732 is an FDA 510(k) clearance for HYSTEROSCOPY PUMP HM6, manufactured by W.O.M. World of Medicine AG. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Special 510(k) pathway after a 120-day FDA review.

K123732 · W.O.M. World of Medicine AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
120d
Days
Class 2
Risk

K123732 is an FDA 510(k) clearance for the HYSTEROSCOPY PUMP HM6. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by W.O.M. World of Medicine AG (Cambridge, US). The FDA issued a Cleared decision on April 4, 2013 after a review of 120 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K123732

510(k) Number K123732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2012
Decision Date April 04, 2013
Days to Decision 120 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
40d faster than avg
Panel avg: 160d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

HIG Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K123732.
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
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852 · Gyrus Acmi, Inc. · Jul 2011
AQUASENS FLUID MONITORING SYSTEM
K031213 · Davol, Inc. · Apr 2003
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc. · Nov 2000