Question 1

What types of medical devices does W.O.M. World of Medicine GmbH primarily manufacture?

Accepted Answer

W.O.M. World of Medicine GmbH specializes in devices for laparoscopic and endoscopic procedures. Their portfolio includes single-use and reusable items like insufflation systems (such as the Synergy Insufflation and GYN-Pump), irrigation tubing sets, endoscopic camera systems, and specialized components like CO₂ gas hoses. They also produce nuclear medicine tools, such as a hand-held detector system, and fluid control solutions like the Aquilex® Fluid Control System. These devices support surgical insufflation, irrigation, illumination, and fluid management in various medical settings.

Question 2

Where is W.O.M. World of Medicine GmbH based, and how does that affect its regulatory oversight?

Accepted Answer

W.O.M. World of Medicine GmbH is based in the United States. As a U.S.-based manufacturer, its devices fall under FDA regulatory jurisdiction. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, indicating they undergo FDA review pathways such as 510(k) clearances or De Novo authorizations. The U.S. location ensures compliance with FDA standards for medical device safety and performance.

Question 3

Which regulatory registries list W.O.M. World of Medicine GmbH’s devices, and why is this important?

Accepted Answer

W.O.M. World of Medicine GmbH’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. Inclusion in these registries confirms that the devices have undergone FDA review and meet regulatory requirements for market authorization. The 510(k) pathway demonstrates that the devices are substantially equivalent to legally marketed predicates, while UDI registration ensures traceability and transparency in the supply chain, which is critical for healthcare providers and regulatory compliance.

Question 4

How are W.O.M. World of Medicine GmbH’s devices classified under FDA regulations, and what does this classification mean?

Accepted Answer

W.O.M. World of Medicine GmbH’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, such as registration and listing requirements. Class II devices involve a higher risk and require premarket notification (510(k)) to ensure safety and effectiveness. The classification reflects the intended use and potential risk of the device, guiding the regulatory pathway and oversight level required by the FDA.

Device	Model / Reference	Registries	Class	Status
Hose for CO2 central gas DISS:DISS, 3m	Z5108-01	FDA UDI	Class I	Active
Full HD-Camera	HDC1600	FDA UDI	Class II	Active
Suction and irrigation Pump for Laparoscopy	P101	FDA UDI	Class II	Active
Tube set for irrigation, single-use	INFLWTBING	FDA UDI	Class II	Active
Hose for CO2 central gas supply DIN:US, 3 m	Z5100-01	FDA UDI	Class I	Active
Heated Tube Set / ISO Connector / disposable	AR-3290-1007	FDA UDI	Class II	Active
Hose for CO2 central gas DIN:US, 5m	INSFCHSEDIN	FDA UDI	Class I	Active
Hose for CO2 gas bottle DIN:US, 1.5m	INSFBHSEDIN	FDA UDI	Class I	Active
Hose for CO2 central gas NF:US, 5m	Z5130-01	FDA UDI	Class I	Active
Tube set for suction, single-use	OTFLWTBING2	FDA UDI	Class II	Active
Tube set for C7050 Irrigation Console	Z0449-32	FDA UDI	Class II	Active
Zoom coupler Arthrex 14-29mm C-Mount	E240	FDA UDI	Class I	Active
HysteroFlow II	WA40620A	FDA UDI	Class II	Active
Integrated tubing, single-use	WA40634A	FDA UDI	Class II	Active
Insufflator 50L	FM134	FDA UDI	Class II	Active
Tube set for vacuum incl. filter, 30-day use	T0504-01	FDA UDI	Class II	Active
Tube set for irrigation, single-use	VP150-10	FDA UDI	Class II	Active
Heating tube set for insufflation, single use	INSFHTDTUB	FDA UDI	Class II	Active
CO2 gas connecter, angled	Z5076-01	FDA UDI	Class I	Active
High pressure hose bottle DIN/bevice US, 1, 5 m	0620050900	FDA UDI	Class I	Active
Tube set for insufflation, single-use	Z0293	FDA UDI	Class II	Active
Remote control for GoFlo Pump A127	72204972	FDA UDI	Class II	Active
Tube set for suction, single-use	T0502-01	FDA UDI	Class II	Active
Tube set for irrigation, single-use	Z1424-01	FDA UDI	Class II	Active
Hose for CO2 central gas supply UNI-US, 3 m	0620050910	FDA UDI	Class I	Active
Tube set for irrigation, single-use	4170.224	FDA UDI	Class II	Active
Insufflator 50L	ZEOSINSUFF	FDA UDI	Class II	Active
Cable remote control	Z0545-01	FDA UDI	Class II	Active
HD-Camera	HDC1500	FDA UDI	Class II	Active
Aquilex® Fluid Control System	AQL-100CBS	FDA UDI	Class II	Active
Tube set for irrigation, single use	T0449-01	FDA UDI	Class II	Active
Tube set for insufflation, single-use	Z0293	FDA UDI	Class II	Active
Gas connector CO2 standard	INSFUNI	FDA UDI	Class I	Active
Hose for CO2 central gas supply UNI:US, 3 m	Z5104-01	FDA UDI	Class I	Active
Hose for CO2 gas bottle Pin:US, 1.5m	Z0499-01	FDA UDI	Class I	Active
Hose for CO2 central gas supply DIN-US, 5 m	0620050905	FDA UDI	Class I	Active
Hose for CO2 gas bottle ISO:US, 1.5m	Z5045-01	FDA UDI	Class I	Active
Heated High-Flow Tube Set	0620050200	FDA UDI	Class II	Active
HysteroLux™ Fluid Management System Scale	PS304	FDA UDI	Class II	Active
GoFlo Pump	A127	FDA UDI	Class II	Active
DISS Adapter for universal gas connection	Z5075-01	FDA UDI	Class I	Active
Tube set for vacuum incl. filter, 30-day use	INTUBWVACC	FDA UDI	Class II	Active
Tube set for vacuum, reusable	AQL-114	FDA UDI	Class II	Active
Gas connector CO2 NIST for central gas supply	Z5010-01	FDA UDI	Class I	Active
Insufflator 50L	FM134	FDA UDI	Class II	Active
Tube set for irrigation, single-use	AQL-110	FDA UDI	Class II	Active
Gamma Finder® Iii	GAMMA FINDER® III	FDA UDI	Class I	Active
Pneumoclear	FM300	FDA UDI	Class II	Active
LAP-Pump	PP120	FDA UDI	Class II	Active
HD-Camera	HDC1500	FDA UDI	Class II	Active

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