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FDA 510(k)

NUVENTUS NV.C™ Surgical Cassette and Tray

K-Number: K243317 · 2025-02-11

ApplicantInfinitum Eta, Ltd.
Decision Date2025-02-11
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NUVENTUS NV.C™ Surgical Cassette and Tray is the device name listed in this FDA 510(k) record. The listed applicant is Infinitum Eta, Ltd.. It received FDA 510(k) clearance on 2025-02-11 under 510(k) 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. The listed applicant is Infinitum Eta, Ltd.. The 510(k) number is K243317.

When did NUVENTUS NV.C™ Surgical Cassette and Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for NUVENTUS NV.C™ Surgical Cassette and Tray?

The FDA 510(k) record lists Infinitum Eta, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Infinitum Eta, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251220NUVENTUS NV.C™ Prosthetic ComponentsK233081NUVENTUS NV.C™ Dental Implant System

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

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