Cleared Traditional

K001096 - BURR HOLE COVER

K001096 is an FDA 510(k) clearance for BURR HOLE COVER, manufactured by Image-Guided Neurologics, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K001096 · Image-Guided Neurologics, Inc. · Neurology device
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Oct 2000
Decision
204d
Days
Class 2
Risk

K001096 is an FDA 510(k) clearance for the BURR HOLE COVER, MODEL XX. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Melbourne, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 204 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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 Image-Guided Neurologics, Inc. devices

FDA 510(k) Submission Details - K001096

510(k) Number K001096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date October 25, 2000
Days to Decision 204 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
56d slower than avg
Panel avg: 148d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 - GXR Cover, Burr Hole

All 17
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K001096.
AESCULAP ABSORBABLE CRANIOFIX
K040080 · Aesculap, Inc. · Mar 2004
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · Synthes (Usa) · Aug 2003
RESORBABLE CRANIAL CLAMPS
K021408 · Synthes (Usa) · Jul 2002
GORE BURR HOLE COVER
K960656 · W.L. Gore & Associates, Inc. · Aug 1996
H-H BURR HOLE CATHETER SUPPORT
K853367 · Holter-Hausner Intl. · Sep 1985