Is this your brand? Sign in to claim ownership.
Sign in to claim this brandW.O.M. World of Medicine GmbH
US
Last updated May 23, 2026
What W.O.M. World of Medicine GmbH makes
W.O.M. World of Medicine GmbH manufactures single-use and reusable devices for laparoscopic and endoscopic procedures, including insufflation systems like the Synergy Insufflation and GYN-Pump, as well as irrigation tubing sets and endoscopic camera systems. Their portfolio also covers specialized components such as CO₂ gas hoses for surgical applications, foot pedals for control, and a Xenon light source for illumination. Nuclear medicine tools, like the hand-held detector system, and fluid control solutions, including the Aquilex® Fluid Control System, are also part of their offerings.
The company’s devices are regulated under FDA pathways, including 510(k) clearances and De Novo authorizations, with products classified primarily as Class I and Class II. These devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does W.O.M. World of Medicine GmbH primarily manufacture?
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.
Where is W.O.M. World of Medicine GmbH based, and how does that affect its regulatory oversight?
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.
Which regulatory registries list W.O.M. World of Medicine GmbH’s devices, and why is this important?
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.
How are W.O.M. World of Medicine GmbH’s devices classified under FDA regulations, and what does this classification mean?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 316305242
Catalogue (197)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tube set for irrigation, single-use | 4170.223 | FDA UDI | Class II | Active |
| Hose for CO2 central gas supply AGA-US, 3 m | 0620050906 | FDA UDI | Class I | Active |
| Switch valve for insufflators | INSFSWITCH | FDA UDI | Class I | Active |
| Heating tube set for insufflation, reusable | Z1415-01 | FDA UDI | Class II | Active |
| Hose for CO2 central gas supply AGA:US, 5 m | Z5107-01 | FDA UDI | Class I | Active |
| Hose for CO2 central gas supply DISS:DISS, 3 m | Z5108-01 | FDA UDI | Class I | Active |
| Hystereoscopy Pump Hm4 | K022449 | FDA 510(k) | Class II | Active |
| W.o.m. Laser U100 | K011175 | FDA 510(k) | Class II | Active |
| W.o.m. Laser U100plus | K032023 | FDA 510(k) | Class II | Active |
| Hys-Surgiflator 150p | K983889 | FDA 510(k) | Class II | Active |
| Flosimple Arthroscopy Pump A120 | K062380 | FDA 510(k) | Class II | Active |
| Surgimat | K926259 | FDA 510(k) | Class II | Active |
| Surgiflator-20 Pim | K955791 | FDA 510(k) | Class II | Active |
| Aquilex Fluid Control System H112 | K112642 | FDA 510(k) | Class II | Active |
| Lap-Wave 3000 (p07) | K990732 | FDA 510(k) | Class II | Active |
| Surgiflator | K921264 | FDA 510(k) | Class II | Active |
| Uropower | K022721 | FDA 510(k) | Class II | Active |
| Arthro-Surgimat | K962114 | FDA 510(k) | Class II | Active |
| Pneumoclear | K170784 | FDA 510(k) | Class II | Active |
| LAP-Pump PP110 | K163320 | FDA 510(k) | Class II | Active |
| Aquilex Fluid Control System AQL-100S | K172040 | FDA 510(k) | Class II | Active |
| Arthro-Surgimat-A103 | K000153 | FDA 510(k) | Class II | Active |
| Pneumoclear | K201361 | FDA 510(k) | Class II | Active |
| Surgiflator-20 Ecu | K981859 | FDA 510(k) | Class II | Active |
| Hys-Surgimat | K934866 | FDA 510(k) | Class II | Active |
| W.o.m. Laser U100 | K023041 | FDA 510(k) | Class II | Active |
| Uro Pro | K042457 | FDA 510(k) | Class II | Active |
| Hysteroscopy Pump Hm6 | K123732 | FDA 510(k) | Class II | Active |
| Hys-Surgiflator Vp | K933847 | FDA 510(k) | Class II | Active |
| Surgimotor | K954470 | FDA 510(k) | Class I | Active |
| ARTHRO-Pump PA304 | K173311 | FDA 510(k) | Class II | Active |
| 40 L High Flow Insufflator F108 | K030837 | FDA 510(k) | Class II | Active |
| Arthro-Surgimat-1500 | K983910 | FDA 510(k) | Class II | Active |
| Insufflator 50L FM134 | K153513 | FDA 510(k) | Class II | Active |
| Arthro-Surgimat-2000 Ecu | K990443 | FDA 510(k) | Class II | Active |
| Arthoscopy Pump A115 | K033927 | FDA 510(k) | Class II | Active |
| 45l Core Insufflator, Model F114 | K063367 | FDA 510(k) | Class II | Active |
| Surgipump | K935763 | FDA 510(k) | Class II | Active |
| Hys-Surgiflator | K924523 | FDA 510(k) | Class II | Active |
| Laser Fiber Gf500 | K021686 | FDA 510(k) | Class II | Active |
| Arthroscopy Pump, Model A107 | K030402 | FDA 510(k) | Class II | Active |
| HD-Camera HDC1000 | K152109 | FDA 510(k) | Class II | Active |
| Iur Fluid Management System | K031616 | FDA 510(k) | Class II | Active |
| 40 L High Flow Insufflator F113 | K060723 | FDA 510(k) | Class II | Active |
| Surgiflator-30 | K973432 | FDA 510(k) | Class II | Active |
| Purevue™ Fms | K250795 | FDA 510(k) | Class II | Active |
| GYN-Pump PH304 | K173489 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.