Cleared Traditional

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set

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

About This 510(k) Submission

K242003 is an FDA 510(k) clearance for the XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 16, 2024, 160 days after receiving the submission on July 9, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K242003 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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