Maxcon Two Gallon Chemotherapy Container
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180983 FDA 510(k)
- FDA Product Code
- MMK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Maxcon Two Gallon Chemotherapy Container is a container, sharps device. It is substantially equivalent to other devices and has a regulation number of 880.5570.
The device is supplied by Ningbo Maxcon Medical Technology Co., Ltd. and has been cleared with a Traditional 510K clearance. It is used in a general hospital setting and has a product code of MMK.
Frequently asked questions
What is the Maxcon Two Gallon Chemotherapy Container used for?
The Maxcon Two Gallon Chemotherapy Container is used in a general hospital setting for containing chemotherapy waste.
Is the Maxcon Two Gallon Chemotherapy Container supplied sterile?
The device data does not specify if the Maxcon Two Gallon Chemotherapy Container is supplied sterile, but it is a sharps device for containing chemotherapy waste.
What is the regulatory classification of the Maxcon Two Gallon Chemotherapy Container?
The Maxcon Two Gallon Chemotherapy Container has a regulation number of 880.5570 and is classified as a substantially equivalent device.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180983 | Class II | Active |
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Manufacturer
- Manufacturer
- Ningbo Maxcon Medical Technology Co., Ltd.
Sources (1)
- FDA 510(k) K180983 24 fields · synced Sep 23, 2026