← Back to catalogue

Omni Instrument Tray

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K182052

by Hologic, Inc.

Identifiers

510(k) Number
K182052 FDA 510(k)
FDA Product Code
KCT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Omni Instrument Tray is a reusable container designed to enclose, protect, and organize hysteroscopic instruments, including the Omni Hysteroscope, sheaths, and removable outflow channels. Constructed from stainless steel, santoprene, and silicone, it ensures secure storage and sterilization of these components while maintaining their integrity and accessibility.

This tray is intended for use in general hospital settings, where it facilitates organized handling and sterilization of hysteroscopic instruments. Supplied as a reusable device, it requires proper cleaning and sterilization procedures between uses. The Omni Instrument Tray holds FDA 510(k) clearance (K182052) and complies with MDR regulatory standards, ensuring its suitability for clinical environments.

Frequently asked questions

What materials is the Omni Instrument Tray made from and how does this affect its durability and sterilization process?

The Omni Instrument Tray is constructed from stainless steel, santoprene, and silicone. These materials are chosen for their durability, resistance to wear, and compatibility with standard sterilization methods (such as autoclaving or chemical sterilization), ensuring the tray remains functional and hygienic for repeated use in clinical settings.

Is the Omni Instrument Tray designed for single-use or reusable applications, and what cleaning and sterilization steps are required?

The Omni Instrument Tray is explicitly designed for reusable applications. Since it encloses hysteroscopic instruments like the Omni Hysteroscope and sheaths, it must undergo proper cleaning and sterilization between uses to maintain safety and functionality. Follow manufacturer guidelines for disinfection and sterilization to ensure compliance with clinical standards.

What types of hysteroscopic instruments does the Omni Instrument Tray accommodate, and how does it improve workflow in a hospital setting?

The tray is engineered to securely hold hysteroscopic instruments, including the Omni Hysteroscope, sheaths, and removable outflow channels. By organizing these components in one reusable container, it streamlines workflow in hospital settings by reducing clutter, simplifying sterilization processes, and ensuring quick, accessible access during procedures.

How does the Omni Instrument Tray comply with regulatory standards, and what does its FDA 510(k) clearance (K182052) indicate?

The Omni Instrument Tray holds FDA 510(k) clearance (K182052) under the Traditional 510(k) pathway, classified as *Substantially Equivalent* to a predicate device. This clearance confirms it meets U.S. regulatory requirements for safety and effectiveness in its intended use—organizing and protecting reusable hysteroscopic instruments in general hospital settings. It also complies with MDR (Medical Device Regulation) standards, ensuring broader international suitability.

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: Omni Instrument Tray | Hologic, PDF Omni® Instrument Tray - Hologic, PDF TRAY LIST - hologic.nl, Omni Instrument Tray (K182052) — FDA 510 (k) | Innolitics, Hologic Omni Instrument Tray Mode d'emploi - Manualzz

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hologic, Inc.

Sources (2)

  • FDA 510(k) K182052 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026