Neptune Waste Management Ststem
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Neptune EUDAMEDFDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Floor Suction Products EUDAMEDSuction Mat (Low Profile), 50x34 FDA UDI
- Model / Reference
- 08858250000635S4 EUDAMED0702-330-000 EUDAMED0702330000 FDA UDI
- Description
- Suction Mat (Low Profile), 50x34 FDA UDI
Identifiers
- Catalog Number
- 0702330000 FDA UDI
- Primary DI / UDI-DI
- 07613252497158 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858250000635S4 EUDAMED
- 510(k) Number
- K012991 FDA 510(k)
- FDA Product Code
- FYD FDA 510(k)GCX FDA UDI
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Suction/irrigation tubing, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.5070 FDA 510(k)
- Regulation Number
- 878.5070 FDA 510(k)880.6740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Neptune Waste Management System is a surgical exhaust apparatus designed to manage and evacuate waste and contaminants from operating rooms and surgical environments. It collects and filters airborne particles, gases, and odors generated during procedures to maintain air quality and reduce cross-contamination risks in clinical settings.
This system is intended for use in surgical facilities and is supplied as a reusable device. It is classified under FDA regulation 878.5070 and has received FDA 510K clearance, with a decision classification of Substantially Equivalent. The system operates within Class II medical device standards and is regulated under the Medical Device Regulation (MDR) framework. It is not intended for MRI environments and must be stored and maintained according to manufacturer guidelines to ensure proper functionality.
Frequently asked questions
Is the Neptune Waste Management System designed for single-use or can it be reused in multiple procedures?
The Neptune Waste Management System is explicitly supplied as a reusable device. Since it is intended for use in surgical environments where air quality and contamination control are critical, it must be cleaned, maintained, and stored according to the manufacturer’s guidelines to ensure proper functionality between uses.
What types of surgical environments is this system intended for, and are there any restrictions on its use?
The Neptune Waste Management System is designed for surgical facilities and operating rooms to manage airborne waste, particles, gases, and odors generated during procedures. It is not intended for MRI environments, and proper storage and maintenance are required to ensure its effectiveness and safety.
How is the regulatory status of this device classified, and what does that mean for its use in clinical settings?
The Neptune Waste Management System is classified under FDA regulation 878.5070 and has received FDA 510K clearance with a decision classification of *Substantially Equivalent*. This means it has been determined to be as safe and effective as a legally marketed device that served as its predicate, adhering to Class II medical device standards. It is also regulated under the Medical Device Regulation (MDR) framework in applicable jurisdictions.
Does the Neptune Waste Management System come in different sizes or models, and if so, how would I determine which one is appropriate for my facility?
While the provided data does not specify exact sizes or models, the system is designed for general surgical exhaust applications and may include variations to accommodate different facility layouts or airflow requirements. The manufacturer’s guidelines would outline compatibility based on room size, ventilation needs, and integration with existing systems. For precise sizing, consulting Stryker Instruments’ technical support or documentation is recommended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K012991 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Instruments
Sources (3)
- FDA 510(k) K012991 24 fields · synced Sep 18, 2026
- FDA UDI f3cccdff-a973-4b84-ab10-bf9ec5ceaacf 36 fields · synced May 30, 2026
- EUDAMED 9b2afb75-fe9e-4025-99d1-611bf1e97574 61 fields · synced Jul 12, 2026