Stryker Visum Surgical Lighting System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031068 FDA 510(k)
- FDA Product Code
- FSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4580 FDA 510(k)
- Regulation Number
- 878.4580 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stryker Visum Surgical Lighting System is a surgical light, ceiling mounted, that provides light for surgical procedures. It is classified as a class 2 device.
The device is supplied as a single unit and is intended for use in general and plastic surgery settings. It has been cleared by the FDA under the traditional clearance type, with the regulation number 878.4580, and has the product code FSY. The device is not specified as single-use or reusable, and its sterility and MRI safety are not stated in the provided data.
Frequently asked questions
What is the Stryker Visum Surgical Lighting System used for?
The Stryker Visum Surgical Lighting System is used to provide light for surgical procedures in general and plastic surgery settings.
Is the Stryker Visum Surgical Lighting System single-use or reusable?
The device is not specified as single-use or reusable in the provided data.
What is the regulatory classification of the Stryker Visum Surgical Lighting System?
The device is classified as a class 2 device and has been cleared by the FDA under the traditional clearance type with regulation number 878.4580.
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: Visum LED II - Stryker, STRYKER VISUM OPERATION MANUAL Pdf Download | ManualsLib, Visum Blade LED - Stryker, PDF Stryker Visum and StrykeCam Operations and Maintenance Manual.pdf, Stryker Visum 300 Assembly, Operation And Maintenance Instructions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031068 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K031068 24 fields · synced Sep 27, 2026