Cleared Traditional

K243317 - NUVENTUS NV.C Surgical Cassette and Tray

K243317 is an FDA 510(k) clearance for NUVENTUS NV.C Surgical Cassette and Tray, manufactured by Infinitum Eta, Ltd.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K243317 · Infinitum Eta, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
112d
Days
Class 2
Risk

K243317 is an FDA 510(k) clearance for the NUVENTUS NV.C™ Surgical Cassette and Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Infinitum Eta, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on February 11, 2025 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Infinitum Eta, Ltd. devices

FDA 510(k) Submission Details - K243317

510(k) Number K243317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2024
Decision Date February 11, 2025
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K243317.
Synthes Graphic Case & Tray System
K241927 · Synthes GmbH · Mar 2025
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
K242564 · Prismatik Dentalcraft, Inc. · Mar 2025
Microdent Sterilization Cassette
K242023 · Implant Microdent System S.L.U. · Feb 2025
System 9 Sterile Battery Container
K242834 · Stryker Instruments · Jan 2025
Klockner Kits
K243128 · SOADCO, S.L. · Dec 2024
Guided Surgery Kit Cases
K241492 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Aug 2024