Identifiers
- 510(k) Number
- K944210 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arthroscope Accessories are supplementary components designed for use with arthroscopic surgical systems. These accessories facilitate minimally invasive joint procedures by enabling fluid irrigation, suction, and instrument passage through arthroscopic ports, supporting visualization and manipulation within the joint space.
Supplied as reusable items, these accessories are intended for use in orthopedic surgical settings. They are cleared under FDA 510(k) K944210 as substantially equivalent to predicate devices, adhering to traditional review pathways. The product code HRX categorizes them under orthopedic advisory committee classifications, with no specific sterility or MRI safety restrictions noted in the data.
Frequently asked questions
Are these accessories designed for single-use or can they be reused in multiple procedures?
These accessories are explicitly labeled as reusable, meaning they are intended for repeated use across multiple arthroscopic procedures. Since they are not sterilized for single-use, proper cleaning, disinfection, and sterilization protocols must be followed between cases to maintain safety and functionality.
What types of procedures are these accessories meant to support in the joint space?
These accessories are supplementary components for arthroscopic surgical systems, enabling critical functions like fluid irrigation, suction, and instrument passage through arthroscopic ports. They assist in visualization and manipulation within joint spaces during minimally invasive orthopedic procedures, such as knee, shoulder, or hip arthroscopy.
How are these accessories categorized in terms of regulatory classification, and what does that mean for their use?
These accessories fall under the FDA product code HRX, which places them under the Orthopedic Advisory Committee (OR) for regulatory oversight. The classification indicates they are cleared under the 510(k) pathway (K944210) as substantially equivalent to prior devices, meaning they follow traditional review standards. This does not impose specific sterility or MRI safety restrictions, but adherence to orthopedic surgical best practices is still required.
Are there any special storage requirements for these reusable accessories?
While the provided data does not specify storage conditions, reusable medical devices like these typically require clean, dry, and protected environments to prevent contamination or damage. Since they are not sterile upon receipt, they must be properly cleaned, disinfected, and sterilized before first use and between procedures. Follow manufacturer guidelines for long-term storage to ensure functionality and safety.
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: Pump accessories - Stryker, Stryker Arthroscopy Product Guide, STRYKER Arthroscope Parts and Accessories For Sale and Wanted, Arthrex - Arthroscopy Accessories
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944210 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K944210 24 fields · synced Sep 19, 2026