Q-5000 Surgical Light, Floor Standing
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K961971 FDA 510(k)
- FDA Product Code
- FSS 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 Q-5000 is a floor-standing surgical light designed to provide high-intensity illumination for endoscopic and minimally invasive procedures. Classified as a surgical light, it delivers fiber-optic light via a cable to endoscopes, ensuring optimal visibility during operations.
This device is intended for use in surgical settings and has received FDA 510(k) clearance under the Traditional pathway. Supplied as a reusable Class II medical device (product code FSS), it is regulated under the U.S. regulation number 878.4580 and is not indicated for MRI environments. Storage and handling follow standard surgical instrument protocols.
Frequently asked questions
What types of procedures is the Q-5000 surgical light primarily designed to support, and how does its illumination system work?
The Q-5000 is specifically designed to provide high-intensity illumination for endoscopic and minimally invasive surgical procedures. Its fiber-optic light delivery system ensures optimal visibility by transmitting light via a cable directly to endoscopes, which is critical in procedures requiring precise visualization of internal structures.
Is the Q-5000 a single-use or reusable device, and what are the standard storage and handling requirements?
The Q-5000 is a reusable Class II medical device, meaning it is intended for repeated use in surgical settings. Storage and handling follow standard protocols for surgical instruments, which typically include cleaning, disinfection, and proper storage in a clean, dry environment to maintain functionality and sterility between uses.
What regulatory pathway was used for FDA clearance of the Q-5000, and what does this mean for its use in clinical settings?
The Q-5000 received FDA 510(k) clearance under the Traditional pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance allows it to be legally used in clinical settings for its intended purpose—providing illumination for endoscopic and minimally invasive procedures—while adhering to U.S. regulatory standards.
Can the Q-5000 be used in an MRI environment, and if not, what are the key limitations to consider?
No, the Q-5000 is explicitly not indicated for use in MRI environments. This limitation is due to potential interference with MRI systems, which require strict adherence to non-ferromagnetic and non-conductive materials to ensure patient safety and imaging accuracy. Always verify the operating room’s equipment compatibility before use.
What are the different models or variations of the Q-5000 available, and how can I identify the correct one for my needs?
The Q-5000 is available in multiple variations, as indicated by the diverse FEI numbers (e.g., 3003574554, 3007123908, etc.) listed in the regulatory data. These variations may correspond to different configurations, features, or accessories. To identify the correct model, consult the manufacturer’s documentation or contact Stryker Endoscopy directly, as specifications like cable length, light intensity, or additional controls may vary between versions.
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: Stryker Light Source | Q5000 - Endoscopy Superstore, K961971 - Q-5000 | FDA 510 (k) | Stryker Endoscopy, Stryker Q5000 ESST Endoscopy Light Source (for Parts)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961971 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K961971 24 fields · synced Sep 19, 2026