Cleared Traditional

K990660 - NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX

K990660 is an FDA 510(k) clearance for NMT NEUROSCIENCES CONTROL UNIT, manufactured by Nmt Neurosciences Implants S.A.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K990660 · Nmt Neurosciences Implants S.A. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 1999
Decision
206d
Days
Class 2
Risk

K990660 is an FDA 510(k) clearance for the NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE .... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Nmt Neurosciences Implants S.A. (Coral Gables, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 206 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 Nmt Neurosciences Implants S.A. devices

FDA 510(k) Submission Details - K990660

510(k) Number K990660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date September 23, 1999
Days to Decision 206 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 148d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K990660.
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · Radionics, Inc. · Aug 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · Radionics, Inc. · Mar 2000
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · Radionics, Inc. · Sep 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
K981246 · Integra Neurocare, LLC · May 1999
DIAMOND II VALVE
K991429 · Phoenix Biomedical Corp. · May 1999