FDA 510(k)

NUVENTUS NV.C Surgical Cassette and Tray

K-Number: K243317 · 2025-02-11

Decision Date2025-02-11

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NUVENTUS NV.C Surgical Cassette and Tray is a medical device manufactured by Infinitum Eta, Ltd.. It received FDA 510(k) clearance on 2025-02-11 under approval number K243317. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVENTUS NV.C Surgical Cassette and Tray?

NUVENTUS NV.C Surgical Cassette and Tray is a medical device that received FDA 510(k) clearance on 2025-02-11. It is manufactured by Infinitum Eta, Ltd.. The 510(k) number is K243317.

When was NUVENTUS NV.C Surgical Cassette and Tray approved by the FDA?

NUVENTUS NV.C Surgical Cassette and Tray received FDA 510(k) clearance on 2025-02-11, under approval number K243317.

What company makes NUVENTUS NV.C Surgical Cassette and Tray?

NUVENTUS NV.C Surgical Cassette and Tray is manufactured by Infinitum Eta, Ltd..

What is the FDA product code for NUVENTUS NV.C Surgical Cassette and Tray?

The FDA product code for NUVENTUS NV.C Surgical Cassette and Tray is KCT.

Other Devices by Infinitum Eta, Ltd.

K233081NUVENTUS NV.C Dental Implant System K251220NUVENTUS NV.C Prosthetic Components

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.