Medsurg Arthrogram Tray
510(k) K854292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854292 | Date26 Nov 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LRO
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Medsurg Arthrogram Tray is a General Surgery Tray designed for arthrogram procedures, a diagnostic imaging technique used to visualize joints via contrast injection. It provides a sterile, organized setup for preparing and administering contrast media during arthrography, ensuring procedural efficiency and safety. The tray is categorized under product code LRO, reflecting its role in supporting diagnostic imaging within general and plastic surgery settings.
This tray is intended for single-use in clinical environments, adhering to sterile field requirements for arthrogram procedures. Supplied as a complete kit, it includes essential components for contrast administration and joint imaging. The device holds FDA 510(k) clearance (K854292) under the Substantially Equivalent (SESE) determination, classified under regulation 878.4370. Storage and handling follow standard sterile medical device protocols, with no noted MRI compatibility restrictions.
Other devices from Medsurg Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medsurg Arthrogram Tray used for?
The Medsurg Arthrogram Tray is designed specifically for arthrogram procedures, a diagnostic imaging technique that involves injecting contrast media into a joint to visualize its structure. It provides a sterile, organized setup to prepare and administer the contrast safely, improving procedural efficiency and accuracy in general and plastic surgery settings.
Is the Medsurg Arthrogram Tray intended for single-use or reuse?
The Medsurg Arthrogram Tray is intended for single-use only in clinical environments. This aligns with sterile field requirements for arthrogram procedures, ensuring patient safety and procedural integrity by preventing cross-contamination.
What components are included in the Medsurg Arthrogram Tray kit?
The tray is supplied as a complete kit, containing all essential components required for contrast administration and joint imaging during arthrogram procedures. While the exact items are not detailed in the provided data, it is designed to streamline the process by consolidating necessary tools and materials in a sterile, organized manner.
How should the Medsurg Arthrogram Tray be stored?
Storage follows standard protocols for sterile medical devices. The tray should be kept in a clean, dry environment, protected from contamination, and handled with care to maintain sterility. Since it is single-use, it should not be reused after opening or exposure to non-sterile conditions.
Are there any MRI compatibility restrictions for this tray?
The provided data does not specify any MRI compatibility restrictions for the Medsurg Arthrogram Tray. However, clinicians should always verify compatibility with the specific MRI system and settings before use, as materials or components not explicitly labeled as MRI-safe may pose risks.