Cleared Traditional

K132044 - CRANIAL LOOP

K132044 is an FDA 510(k) clearance for CRANIAL LOOP, manufactured by Neos Surgery S.L. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K132044 · Neos Surgery S.L · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2013
Decision
90d
Days
Class 2
Risk

K132044 is an FDA 510(k) clearance for the CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SY.... Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Neos Surgery S.L (Alexandria, US). The FDA issued a Cleared decision on September 30, 2013 after a review of 90 days - within the typical 510(k) review window.

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 Neos Surgery S.L devices

FDA 510(k) Submission Details - K132044

510(k) Number K132044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2013
Decision Date September 30, 2013
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K132044.
OSSDSIGN Cranioplug
K181539 · Ossdsign AB · Oct 2018
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical · Jul 2018
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · St Jude Medical · Jun 2016
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · Biomet Microfixation · Jun 2013
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · Synthes (Usa) · Nov 2004