SteriZign Signatur Device Protection System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171520 FDA 510(k)
- FDA Product Code
- KCT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SteriZign Signatur Device Protection System is a device designed to organize, transport, store, and protect surgical and other medical devices between uses. It is intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization process.
The system is supplied as a reusable device protection system for use in healthcare settings. It has received FDA 510(k) clearance under K-number K171520 and is manufactured by Sterizign Precision Technologies, LLC.
Frequently asked questions
What is the SteriZign Signatur Device Protection System used for?
The SteriZign Signatur Device Protection System is designed to organize, transport, store, and protect surgical and other medical devices between uses, and it allows sterilization of the enclosed devices during a pre-vacuum steam sterilization process.
Is the SteriZign Signatur Device Protection System reusable or single-use?
The system is supplied as a reusable device protection system for use in healthcare settings, meaning it is designed for multiple uses after proper cleaning and sterilization between cycles.
What type of sterilization process is the SteriZign Signatur Device Protection System compatible with?
The system is intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization process, which is a common method in healthcare facilities for achieving sterility.
Who manufactures the SteriZign Signatur Device Protection System and what is its FDA authorization?
The SteriZign Signatur Device Protection System is manufactured by Sterizign Precision Technologies, LLC and has received FDA 510(k) clearance under K-number K171520.
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: SteriZign Signatur Device Protection System (K171520) — FDA 510(k ..., K171520 FDA 510(k) - SteriZign Signatur Device Protection System, Sterilization Trays - SteriZign® Precision Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171520 | Class II | Active |
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Manufacturer
- Manufacturer
- Sterizign Precision Technologies, LLC
Sources (1)
- FDA 510(k) K171520 24 fields · synced Sep 22, 2026