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Various Non-Sterile Custom Trays/Kits

by Surgipro Central, Inc.

510(k) K924690

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)SEKD Traditional NumberK924690 Date16 Jul 1993ClearedStatusActive

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  • Withdrawn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
MCY
Device Class
Class II
Regulation
21 CFR Part 880.5075
Advisory Committee
General Hospital
FDA Decision
SEKD

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.

These devices are custom wound dressing kits designed for general hospital use. They are categorized as wound dressing kits and include various components tailored for specific medical applications, though their exact contents vary by kit.

The kits are non-sterile and supplied as reusable or single-use trays, depending on the configuration. They are classified under FDA device class II (MCY) and were granted 510(k) clearance (K924690) in 1993. No MRI safety or sterility requirements beyond non-sterile classification are specified, and storage conditions are not detailed in the regulatory data.

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 are these custom wound dressing kits designed for?

    These custom wound dressing kits are designed for general hospital use, providing tailored components for various medical applications. They are categorized as wound dressing kits and can be configured to meet specific clinical needs, though the exact contents vary by kit. Their versatility makes them suitable for a range of wound care scenarios in hospital settings.

  • Are these trays sterile or non-sterile?

    These trays are explicitly labeled as non-sterile. Non-sterile products are intended for use in environments where sterility is not required, such as certain preparation or storage stages of wound care. Always follow facility protocols for handling non-sterile items to ensure proper infection control.

  • How are these kits supplied—single-use or reusable?

    These kits are supplied in two configurations: reusable or single-use trays. The choice depends on the specific kit configuration and the intended use case. Reusable trays must be cleaned, disinfected, and sterilized between uses according to established protocols, while single-use trays are designed for one-time use only.

  • What regulatory classification do these kits hold?

    These custom wound dressing kits fall under FDA device class II (MCY) and were granted 510(k) clearance under the traditional review pathway. The clearance number is K924690, and they were approved in 1993. This classification indicates they are subject to special controls to ensure their safety and effectiveness.

  • Are there any special storage requirements for these kits?

    The regulatory data does not specify detailed storage conditions for these kits. However, as non-sterile items, they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and contaminants. Always follow manufacturer guidelines and facility protocols to maintain their integrity and usability.