BEUDAMED
    Product Code: GXR FDA class 2 21 CFR 882.5250

    Cover, Burr Hole

    Neurology

    The Burr Hole Cover is an implanted neurosurgical device used to seal small circular openings made in the skull during cranial access procedures, restoring the skull's protective integrity after procedures such as deep brain stimulation lead placement or biopsy. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is GXR under regulation 21 CFR 882.5250 in the Neurology specialty. The implant flag is active for this device.

    View on FDA
    510(k)s
    29
    FEI Numbers
    50
    Registration Numbers
    50
    Unique Applicants
    19
    Years Active
    41

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    Basic Information

    Product Code
    GXR
    Device Class
    FDA class 2
    Regulation Number
    882.5250
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 29 510(k) clearances via K numbers.

    K Number Device Name
    K253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
    K240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
    K221606 Absorbable Cranial Flap Fixation System
    K192310 Flap Fixator, Burr Hole Cover
    K192162 NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
    K181539 OSSDSIGN Cranioplug
    K181382 GuardianTM Burr Hole Cover System
    K160739 Cranial COVER
    K152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
    K140309 CRANIOPLUG
    K141368 NEUROPACE BURR HOLE COVER
    K132044 CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
    K123633 TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
    K130309 RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
    K123163 NEUROPACE BURR HOLE COVER MODEL 8110
    K101235 CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
    K091692 AESCULAP PEEK CRANIOFIX
    K071138 CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
    K042986 MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
    K041611 SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
    K040080 AESCULAP ABSORBABLE CRANIOFIX
    K031654 SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
    K021408 RESORBABLE CRANIAL CLAMPS
    K010361 MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
    K002334 MACROPORENS CRANILOC
    K001096 BURR HOLE COVER, MODEL XX
    K960656 GORE BURR HOLE COVER
    K913490 PHOENIX BURR HOLE BUTTON, BURR 1
    K853367 H-H BURR HOLE CATHETER SUPPORT

    FEI Numbers

    This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.