Cleared Traditional

K143024 - CAS-One Liver (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143024 · Cascination AG · General & Plastic Surgery device
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Apr 2015
Decision
189d
Days
Class 2
Risk

K143024 is an FDA 510(k) clearance for the CAS-One Liver. Classified as Tracking, Soft Tissue, Intraoperative (product code OEW), Class II - Special Controls.

Submitted by Cascination AG (Bern, CH). The FDA issued a Cleared decision on April 28, 2015 after a review of 189 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.4560 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K143024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2014
Decision Date April 28, 2015
Days to Decision 189 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 114d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEW Tracking, Soft Tissue, Intraoperative
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition For Open Liver Surgical Procedures Where Image-guidance May Be Appropriate And Where The Patient Can Tolerate Long Apneic Periods Under General Anesthesia.
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 & Plastic Surgery devices follow this clearance model.