NUVENTUS NV.C Surgical Cassette and Tray
510(k) K243317
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243317 | Date11 Feb 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KCT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NUVENTUS NV.C Surgical Cassette and Tray is a sterile barrier system designed to enclose and protect medical devices during sterilization and storage. It serves as a container for packaging instruments, implants, or other surgical items to maintain sterility and prevent contamination before use in surgical procedures. This device is classified under product code KCT, aligning with general hospital surgical instrumentation requirements. Its primary function is to ensure the integrity of contained items through the sterilization process while facilitating organized handling in clinical settings.
The NUVENTUS NV.C Surgical Cassette and Tray is supplied as a single-use, sterile device intended for use in hospital operating rooms or sterile processing departments. It is cleared by the FDA under 510(k) clearance number K243317, following a Traditional review pathway and classified as a Class 2 device for general hospital use. The tray is designed to accommodate various sizes of medical devices, ensuring compatibility with standard sterilization methods. Storage should adhere to manufacturer guidelines to preserve sterility until first use, with no indication of MRI compatibility or reusable applications.
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Questions
AI-generated answers, 1 Oct 2026
What is the NUVENTUS NV.C Surgical Cassette and Tray used for?
The NUVENTUS NV.C Surgical Cassette and Tray is designed as a sterile barrier system to enclose and protect medical devices, instruments, implants, or surgical items during sterilization and storage. Its primary purpose is to maintain sterility and prevent contamination, ensuring the integrity of contained items throughout the sterilization process and facilitating organized handling in clinical settings like operating rooms or sterile processing departments.
Is the NUVENTUS NV.C Surgical Cassette and Tray single-use or reusable?
The NUVENTUS NV.C Surgical Cassette and Tray is explicitly intended for single-use only. This design choice ensures that sterility is preserved for the duration of its intended use, reducing the risk of cross-contamination between procedures. After use, the tray should be discarded to comply with sterile barrier system protocols.
How should the NUVENTUS NV.C Surgical Cassette and Tray be stored before first use?
Storage of the NUVENTUS NV.C Surgical Cassette and Tray must follow the manufacturer’s guidelines to preserve its sterility until first use. The tray should be kept in a clean, dry environment, protected from physical damage, moisture, and direct sunlight. Avoid storing it in areas with high humidity or extreme temperatures, as these conditions could compromise the sterility and structural integrity of the packaging.
What sizes of medical devices can the NUVENTUS NV.C Surgical Cassette and Tray accommodate?
The NUVENTUS NV.C Surgical Cassette and Tray is designed to accommodate various sizes of medical devices, ensuring compatibility with standard surgical instruments and implants. While exact dimensions are not specified, its modular design allows for flexibility in organizing and securing items of differing shapes and sizes within the sterile barrier. Always refer to the manufacturer’s instructions for specific sizing guidance and optimal packing techniques.
What regulatory pathway does the NUVENTUS NV.C Surgical Cassette and Tray follow?
The NUVENTUS NV.C Surgical Cassette and Tray has received FDA clearance under the 510(k) pathway, specifically clearance number K243317. It was reviewed through the Traditional review process and classified as a Class 2 device under product code KCT, which aligns with general hospital surgical instrumentation requirements. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device.