Cleared Traditional

K002334 - MACROPORENS CRANILOC

K002334 is an FDA 510(k) clearance for MACROPORENS CRANILOC, manufactured by Macropore Biosurgery, Inc.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K002334 · Macropore Biosurgery, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
274d
Days
Class 2
Risk

K002334 is an FDA 510(k) clearance for the MACROPORENS CRANILOC. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 274 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 Macropore Biosurgery, Inc. devices

FDA 510(k) Submission Details - K002334

510(k) Number K002334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date May 02, 2001
Days to Decision 274 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
126d slower than avg
Panel avg: 148d · This submission: 274d
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 16
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K002334.
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