Sterrad 100NX Sterilizer Duo Cycle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111377 FDA 510(k)
- FDA Product Code
- MLR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6860 FDA 510(k)
- Regulation Number
- 880.6860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sterrad 100NX Sterilizer Duo Cycle is a chemical sterilizer designed for the sterilization of medical devices. It utilizes a chemical process to ensure the effective decontamination of instruments within a clinical setting.
This device is regulated under FDA 510k clearance as a class 2 medical device. It is intended for use in general hospital environments to support standard sterilization protocols.
Frequently asked questions
What is the primary function of the Sterrad 100NX Sterilizer Duo Cycle?
This device is a chemical sterilizer designed to perform the decontamination of medical instruments within a clinical setting. It is intended to support standard sterilization protocols in general hospital environments.
How is this device regulated for clinical use?
The Sterrad 100NX Sterilizer Duo Cycle is classified as a class 2 medical device. It has received FDA 510k clearance, which indicates that the device has been determined to be substantially equivalent to other legally marketed devices.
What is the regulatory classification for this sterilizer?
The device is categorized under regulation number 880.6860, which pertains to chemical sterilizers. It is assigned to the General Hospital advisory committee and is identified by product code MLR.
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 | K111377 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K111377 24 fields · synced Sep 23, 2026