Cleared Traditional

K003759 - AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR

K003759 is an FDA 510(k) clearance for AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K003759 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
204d
Days
Class 2
Risk

K003759 is an FDA 510(k) clearance for the AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Aesculap, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 204 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - 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

FDA 510(k) Submission Details - K003759

510(k) Number K003759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date June 28, 2001
Days to Decision 204 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 148d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 66
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K003759.
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K042728 · Novus Monitoring, Ltd. · Oct 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · Integra LifeSciences Corporation · Apr 2004
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc. · Oct 1999
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
K980380 · Diametrics Medical, Ltd. · Jul 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · Johnson & Johnson Professionals, Inc. · Jul 1999