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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K223734

ENT EM · Brainlab AG · decided 2023-04-27 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm52172Brainlab SEHAW PGW04056481144685
Curve Navigation17702Brainlab SEHAW OLO PGW04056481146702
EM Patient Reference18099-24Brainlab SEHAW PGW04056481004804
Kick 2 Navigation Station EM18202Brainlab SEHAW PGW04056481143725
Starlink Suction Tube Frazier-Tip 45° Angled 10 FR55790-70Brainlab SEHAW PGW04056481001421
Starlink Suction Tube Frazier-Tip 70° Angled 8 FR55790-55Brainlab SEHAW PGW04056481001452
Starlink Suction Tube Frazier-Tip 45° Angled 8 FR55790-75Brainlab SEHAW PGW04056481001414
EM Registration Pointer18099-23Brainlab SEHAW PGW04056481004811
Curve Navigation 1770017701Brainlab SEHAW OLO PGW04056481144500
EM Pointer18099-02CBrainlab SEHAW PGW04056481004927
Navigation SW ENT EM1.2Brainlab SEHAW PGW04056481138813
Curve Navigation 1770017700Brainlab SEHAW OLO PGW04056481142520
Starlink Suction Tube Frazier-Tip 70° Angled 10 FR55790-65Brainlab SEHAW PGW04056481001438
EM Short Pointer18099-27Brainlab SEHAW PGW04056481140410
Starlink Suction Tube Olive-Tip 45° Angled 8 FR55790-05ABrainlab SEHAW PGW04056481001551
Skull Reference Base EM18099-06Brainlab SEHAW PGW04056481004866
Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw52173Brainlab SEHAW PGW04056481144692
Starlink Suction Tube Olive-Tip 70° Angled 8 FR55790-50ABrainlab SEHAW PGW04056481001469
EM Instrument Tracker18099-05ABrainlab SEHAW PGW04056481004873