NUVENTUS NV.C Surgical Cassette and Tray— 510(k) K243317

Name: FDA 510(k) clearance K243317
Creator: U.S. Food and Drug Administration
Published: 2025-02-11

Substantially Equivalent

Infinitum Eta, Ltd.

FDA 510(k) clearance K243317 for NUVENTUS NV.C Surgical Cassette and Tray, Substantially Equivalent on 2025-02-11. Applicant: Infinitum Eta, Ltd.. Device class: 2.

Clearance details

Applicant: Infinitum Eta, Ltd.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2024-10-22
Decision date: 2025-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikva, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.