Isolyser Sharps Room System, Model 800 +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090156 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
- Models / Variants
- Isolyser Sharps Room System, Model 800 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 Isolyser Sharps Room System and Sharps Management System are disposable sharps containers designed for the safe and effective disposal of used medical sharps. These systems are intended for use in both clinical and non-clinical settings to manage contaminated sharps and medical waste.
These single-use, over-the-counter devices are supplied in various models including 800, 2400, 4000, and 10000. The systems have received FDA 510k clearance for their intended use in the disposal of medical waste.
Frequently asked questions
What is the intended use of the Isolyser Sharps Management System?
These systems are designed for the safe and effective disposal of used medical sharps. They are intended to manage contaminated sharps and medical waste in both clinical and non-clinical environments.
Are these sharps containers intended for single or multiple use?
The Isolyser Sharps Room System and Sharps Management System are single-use, disposable devices. They are designed to be used once for the containment of medical waste and should not be reused.
What models are available for this sharps disposal system?
The system is available in four distinct models to accommodate different disposal needs: Model 800, Model 2400, Model 4000, and Model 10000.
Has this device received regulatory clearance?
Yes, the Isolyser Sharps Room System and Sharps Management System have received FDA 510k clearance for their intended use in the disposal of medical waste.
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. Sources consulted: Isolyser Sharps Room System, Model 800; Isolyser Sharps Management ..., Sharps Disposal Made Easy - WasteWise Isolyser®/SMS®, Isolyser Home Sharps Management (Hsm), Model 800m; Isoly Sharps ..., Isolyser?/SMS? Sharps Management System, SMS2400, 3 Liter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090156 | Class II | Active |
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Manufacturer
- Manufacturer
- Wcm Waste & Compliance Management, Inc.
Sources (1)
- FDA 510(k) K090156 24 fields · synced Sep 26, 2026