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Cameo Percutaneous Skin Prep Trays

by Cameo, Inc.

510(k) K922961

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 NumberK922961 Date23 Mar 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  • Withdrawn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)

Full name
Various Cameo Med Percutaneous Skin Prep Trays,
510(k) Number
FDA Product Code
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
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.

The Cameo Percutaneous Skin Prep Trays are sterile, disposable trays designed for pre-surgical skin preparation. These trays are intended for use in general and plastic surgery procedures to facilitate the preparation of the skin prior to incision or invasive procedures. They are classified under product code KKX and fall under the FDA’s classification for percutaneous skin preparation devices.

The trays are supplied as single-use, sterile kits containing all necessary components for skin disinfection. They are intended for use in controlled surgical environments and are regulated under FDA 510(k) clearance (K922961). No MRI safety or reusable specifications are noted in the regulatory data. Storage should follow manufacturer guidelines to maintain sterility and integrity until use.

Other devices from Cameo, Inc.

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 Cameo Percutaneous Skin Prep Tray used for?

    The Cameo Percutaneous Skin Prep Tray is designed specifically for pre-surgical skin preparation in general and plastic surgery procedures. It facilitates disinfection of the skin prior to incision or invasive procedures, ensuring a clean surgical field. The tray includes all necessary components for effective skin disinfection, making it ideal for controlled surgical environments where sterility is critical.

  • Are these trays reusable or single-use?

    These trays are intended for single-use only. The design and regulatory classification (FDA 510(k) clearance) confirm they are disposable to maintain sterility and hygiene standards in surgical settings. Reuse is not recommended or supported by the manufacturer.

  • How should the trays be stored to maintain sterility?

    Storage instructions are provided by the manufacturer to preserve sterility and integrity until use. The trays should be kept in their original packaging, protected from moisture, contamination, and physical damage. Follow the manufacturer’s guidelines to ensure the components remain effective and uncontaminated prior to use.

  • What types of procedures are these trays approved for?

    The trays are approved for use in general and plastic surgery procedures where percutaneous skin preparation is required. They are not indicated for MRI environments, as no MRI safety information is provided in the regulatory data. Their intended use aligns with the FDA’s classification for percutaneous skin preparation devices (product code KKX).

  • Do these trays include all necessary components for skin disinfection?

    Yes, the Cameo Percutaneous Skin Prep Tray is supplied as a complete, single-use kit containing all required components for skin disinfection. This eliminates the need for additional supplies, streamlining the pre-surgical preparation process in controlled surgical environments.