Identifiers
- 510(k) Number
- K033222 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)
Olympus Sterilization Trays are instrument trays designed for the sterilization of medical devices. They are substantially equivalent to predicate devices cleared under the FDA 510(k) process.
These trays are supplied by Olympus Winter & Ibe GmbH and are intended for use in general hospital settings. They are provided as non-sterile, reusable devices for holding and organizing instruments during sterilization cycles.
Frequently asked questions
What are Olympus Sterilization Trays used for?
Olympus Sterilization Trays are designed to hold and organize medical instruments during sterilization cycles, ensuring proper positioning and protection of devices while they undergo reprocessing in general hospital environments.
Are Olympus Sterilization Trays supplied sterile or non-sterile?
These trays are provided as non-sterile devices, meaning they must be cleaned and sterilized by the user before first use and between subsequent uses to maintain infection control standards.
Can Olympus Sterilization Trays be reused after sterilization?
Yes, Olympus Sterilization Trays are designed as reusable instruments; they can be cleaned, sterilized, and reused multiple times following the manufacturer’s instructions for cleaning and maintenance to ensure continued safety and functionality.
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: OLYMPUS STERILIZATION TRAYS (K033222) — FDA 510(k) | Innolitics, Olympus Winter & Ibe GmbH - FDA 510 (k) Cleared Devices, Olympus WA05991A Instrument tray, for flexible… - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033222 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA 510(k) K033222 24 fields · synced Sep 25, 2026