Olympus Working Element for Probes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992141 FDA 510(k)
- FDA Product Code
- FDC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Olympus Working Element for Probes is a mechanical accessory designed for endoscopes used in urological procedures. It facilitates the insertion and manipulation of probes, such as laser fibers, or guiding tubes and injection cannulas.
This device is intended for diagnostic and therapeutic applications in gastroenterology and urology. It is supplied as a single-use component and is not reusable. The device is not sterilized and must be used in accordance with the manufacturer's instructions.
Frequently asked questions
What is the Olympus Working Element for Probes used for?
It is a mechanical accessory designed for endoscopes used in urological procedures. It facilitates the insertion and manipulation of probes, such as laser fibers, or guiding tubes and injection cannulas.
Is this device intended for single-use or reuse?
The device is supplied as a single-use component and is not reusable.
Is the Olympus Working Element for Probes sterile?
The device is not sterilized and must be used in accordance with the manufacturer's instructions.
What are the intended applications for this device?
It is intended for diagnostic and therapeutic applications in gastroenterology and urology.
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 WORKING ELEMENT FOR PROBES - Innolitics, PDF K992141 - Olympus Working Element for Probes, OLYMPUS WORKING ELEMENT FOR PROBES 510(k) K992141 - 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 | K992141 | Class II | Active |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA 510(k) K992141 24 fields · synced Sep 21, 2026