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Medsurg Arthrogram Tray

by Medsurg Industries, Inc.

510(k) K854292

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854292 Date26 Nov 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.