Cleared Traditional

K242003 - XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242003 · Aesculap, Inc. · Neurology device
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Dec 2024
Decision
160d
Days
Class 2
Risk

K242003 is an FDA 510(k) clearance for the XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 16, 2024 after a review of 160 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K242003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2024
Decision Date December 16, 2024
Days to Decision 160 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 148d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 257
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