BEUDAMED
    Product Code: ERL FDA class 2 21 CFR 874.4250

    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    Ear, Nose, Throat

    The ENT surgical drill (electric or pneumatic, including handpiece) is a powered instrument used for precision bone removal and shaping in ENT surgical procedures such as mastoidectomy, cochlear implantation surgery, and sinus procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is ERL, regulated under 21 CFR 874.4250 in the Ear, Nose, Throat specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    91
    FEI Numbers
    125
    Registration Numbers
    125
    Unique Applicants
    53
    Years Active
    47

    Basic Information

    Product Code
    ERL
    Device Class
    FDA class 2
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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 91 510(k) clearances via K numbers.

    K Number Device Name
    K243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
    K233958 hekaDrill
    K221184 ORiGO System
    K213221 AMADEO, M-UK1015 (incl. attachments and accessories)
    K212650 Celeris, Disposable Sinus Debrider
    K211490 Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
    K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
    K190715 EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
    K180063 OCM-G1 Attachment
    K171840 Stryker Consolidated Operating Room Equipment (CORE) 2 Console
    K163247 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
    K161376 DragonFly Surgical Drill System
    K161101 PolypVac Microdebrider (3.3mm and 4.0mm)
    K152744 DIEGO ELITE DRILL
    K150969 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
    K152641 Pi Drive Plus Motor, Extender
    K150728 XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
    K143492 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
    K141935 STRYKER S2 DRILL
    K131053 ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
    K133133 LAURIMED POLYPVAC MICRODEBRIDER
    K121678 DTAD
    K112593 STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
    K083720 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
    K081814 REPROCESSED ENT SHAVERS
    K080052 STRYKER ESSX WITH NAVIGATION MOUNT
    K080722 PRIMADO SURGICAL DRILL
    K081277 XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
    K073633 STRYKER ESSX MICRODEBRIDER SYSTEM
    K073255 XPS 3000 SYSTEM
    K053262 KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
    K041523 XPS 3000 SYSTEM
    K041413 XPS 3000 SYSTEM
    K040300 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
    K034004 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
    K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K021098 DAUM-LECTRIC MRI DRILLING MACHINE
    K021811 UNIDRIVE II PLUS DISPOSABLE TUBING SET
    K020594 DIEGO POWERED DISSECTOR AND DRILL SYSTEM
    K012456 SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
    K011321 MODIFICATION TO XPS 3000 SYSTEM
    K011381 HUMMER IV MICRODEBRIDER SYSTEM
    K003994 KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
    K002224 XPS 3000 SYSTEM
    K002828 XPS NITRO SYSTEM
    K992994 TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
    K990038 HUMMER TRAK SYSTEM
    K983050 PNEUMATIC CUTTER SYSTEM
    K983224 XPS DRILL SYSTEM
    K981041 SLT BIPOLAR SHEATH
    K981637 INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
    K974174 ULTRABUR
    K972057 POWERTREK INSTRUMENTS
    K972584 STRYKER HUMMER II MICRODEBRIDER SYSTEM
    K973286 ENT IRRIGATING PUMP (70327700)
    K972865 PROMEX ENT TISSUE REMOVAL SYSTEM
    K972453 XPS STRAIGHTSHOT MICRORESECTOR
    K970965 MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
    K964548 APEX UNIVERSAL DRIVE SYSTEM
    K965080 ANSPACH MICROMAX SYSTEM
    K963246 TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
    K962163 MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
    K961192 IRRIGATION SYSTEM
    K954989 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
    K954796 MICRO-INGRESSOR HANDIPIECE
    K954715 MICRO-PLANER HANDPIECE
    K952681 STRYKER HUMMER II MICRODEBRIDER SYSTEM
    K951263 INTRAARC DRIVE SYSTEM
    K950964 KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
    K945659 BLACKSTAR(TM) STAR SYSTEM
    K943569 STRYKER TOTAL PERFORMANCE SYSTEM
    K945438 EDI-BUR MICRODRILL SYSTEMS
    K940016 ELECTRIC SURGICAL DRILL
    K944476 APEX UNIVERSAL DRIVE SYSTEM
    K943108 MEDNEXT MICRO-DRILL
    K940710 STRYKER MICRODEBRIDER SYSTEM
    K914346 DRILL MODULES MODELS 2116/2117
    K905800 X-T AIR DRILL
    K873154 TREACE MAGNUM OTO-TOOL SYSTEM
    K862807 TREACE DRILL SYSTEM
    K854332 MICRO-AIRE STAPES DRILL SYSTEM
    K854331 MICRO-AIRE OTO/NEURO DRILL SYSTEM
    K841813 TISSUE INTEGRATED PROSTHESIS DRILL
    K833875 SHEA FOOTPLATE MICRODRILL
    K833874 SHEA MIDDLE EAR MICRODRILL
    K831946 SURGICAL DRILL-ELECTRIC-HANDPIECE
    K822008 TORX OR TYPE MICRO MOTOR HANDPIECE
    K802463 MICRO-SURGICAL POWER INSTRUMENT SYSTEM
    K792159 FISCH DRILL SYSTEM
    K791407 WOMED NICRO-CRAFT POWER SYSTEM
    K781418 XOMED TRANSSPHENOIDAL HANDPIECE

    FEI Numbers

    This FDA classification entry is associated with 125 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 125 registration numbers. Click on an entry to view related FDA registrations.