Packaging Tray and Components
by Vygon Us, LLC 510(k)
Active
510(k) K040707
Overview
This device is a sterilization wrap (Product Code FRG) designed to protect medical devices during sterilization and storage. It consists of a tray and associated components intended to maintain sterility and integrity of packaged items within a hospital or clinical setting.
The Packaging Tray and Components are supplied as a reusable system for use in general hospital environments. Authorized under FDA 510(k) clearance (K040707) as substantially equivalent (SESE) to a predicate device, it adheres to 21 CFR 880.6850 for sterilization wrap. No specific sterility or MRI safety information is provided in the regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040707 | Date16 Apr 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vygon Us, LLC
Questions
What is the primary purpose of the Packaging Tray and Components from Vygon US, LLC, and how does it function in a clinical setting?
The Packaging Tray and Components are designed to protect medical devices during sterilization and storage, ensuring sterility and integrity of packaged items in a hospital or clinical environment. The reusable system helps maintain a controlled environment for items like surgical instruments or supplies, preventing contamination while they are processed or stored.
Is this device intended for single-use or reusable applications, and how does that affect its use in a hospital?
This device is explicitly supplied as a reusable system, meaning it is engineered to withstand repeated sterilization cycles in a hospital setting. Its design allows for multiple uses while maintaining the sterility and protection of the items it contains, making it cost-effective for general hospital environments.
What regulatory pathway was followed for this device, and what does that mean for its use in medical facilities?
The Packaging Tray and Components were cleared through the FDA’s 510(k) process (K040707) under a Special Review by the General Hospital (HO) Advisory Committee. The clearance was granted as Substantially Equivalent (SESE) to a predicate device, meaning it meets the same regulatory standards for sterilization wrap (Product Code FRG) under 21 CFR 880.6850. This ensures compliance with FDA requirements for reusable sterilization packaging.
How should the Packaging Tray and Components be stored when not in use, and are there any special considerations?
While the device is reusable, the regulatory submission does not specify storage conditions beyond typical hospital protocols for reusable medical packaging. It is recommended to follow facility guidelines for cleaning, drying, and storage to maintain its integrity and prevent contamination between uses. Since it is designed for repeated sterilization, proper handling—such as avoiding moisture or physical damage—will ensure longevity and effectiveness.