# K243317: NUVENTUS NV.C™ Surgical Cassette and Tray

- Pathway: 510(k) (Traditional)
- Applicant: Infinitum Eta, Ltd.
- Decided: Feb 11, 2025 after 112 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K844002 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201878: ST-Z5, Z-Systems AG (2021) Summary page 5.

## Indications for use
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices. The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads. The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.

Source page: https://510kreport.com/device/K243317
Methodology: https://510kreport.com/methodology