Cleared Traditional

K150898 - LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (FDA 510(k) Clearance)

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

K150898 · Moller Medical GmbH · Neurology device
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Dec 2015
Decision
260d
Days
Class 2
Risk

K150898 is an FDA 510(k) clearance for the LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Moller Medical GmbH (Fulda, DE). The FDA issued a Cleared decision on December 18, 2015 after a review of 260 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 Moller Medical GmbH devices

Submission Details

510(k) Number K150898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date December 18, 2015
Days to Decision 260 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 148d · This submission: 260d
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.

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All 257
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