Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EQLLaryngostroboscope1Product Code
- EOQBronchoscope (Flexible Or Rigid)2Product Code
- EOXEsophagoscope (Flexible Or Rigid)2Product Code
- BSTCurette, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- BWHForceps, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- EMXBalloon, Epistaxis1Product Code
- ENWCatheter, Nasopharyngeal1Product Code
- ENZTelescope, Laryngeal-Bronchial2Product Code
- EOBNasopharyngoscope (Flexible Or Rigid)2Product Code
- EQHSource, Carrier, Fiberoptic Light1Product Code
- EQJBur, Ear, Nose And Throat1Product Code
- EQNLaryngoscope, Nasopharyngoscope2Product Code
- ERAOtoscope1Product Code
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece2Product Code
- K233958hekaDrill2Cleared 510(K)
- K221184ORiGO System2Cleared 510(K)
- K213221AMADEO, M-UK1015 (incl. attachments and accessories)2Cleared 510(K)
- K212650Celeris, Disposable Sinus Debrider2Cleared 510(K)
- K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-0002Cleared 510(K)
- K200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece2Cleared 510(K)
- K190715EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand2Cleared 510(K)
- K180063OCM-G1 Attachment2Cleared 510(K)
- K171840Stryker Consolidated Operating Room Equipment (CORE) 2 Console2Cleared 510(K)
- K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider2Cleared 510(K)
- K161376DragonFly Surgical Drill System2Cleared 510(K)
- K161101PolypVac Microdebrider (3.3mm and 4.0mm)2Cleared 510(K)
- K152744DIEGO ELITE DRILL2Cleared 510(K)
- K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces2Cleared 510(K)
- K152641Pi Drive Plus Motor, Extender2Cleared 510(K)
- K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole2Cleared 510(K)
- K143492OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece2Cleared 510(K)
- K141935STRYKER S2 DRILL2Cleared 510(K)
- K131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM2Cleared 510(K)
- K133133LAURIMED POLYPVAC MICRODEBRIDER2Cleared 510(K)
- K121678DTAD2Cleared 510(K)
- K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM2Cleared 510(K)
- K083720OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K2Cleared 510(K)
- K081814REPROCESSED ENT SHAVERS2Cleared 510(K)
- K080052STRYKER ESSX WITH NAVIGATION MOUNT2Cleared 510(K)
- K080722PRIMADO SURGICAL DRILL2Cleared 510(K)
- K081277XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)2Cleared 510(K)
- K073633STRYKER ESSX MICRODEBRIDER SYSTEM2Cleared 510(K)
- K073255XPS 3000 SYSTEM2Cleared 510(K)
- K053262KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES2Cleared 510(K)
- K041523XPS 3000 SYSTEM2Cleared 510(K)
- K041413XPS 3000 SYSTEM2Cleared 510(K)
- K040300STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)2Cleared 510(K)
- K034004DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE2Cleared 510(K)
- K023070SODEM HIGH SPEED SYSTEM (PNEUMATIC)2Cleared 510(K)
- K021098DAUM-LECTRIC MRI DRILLING MACHINE2Cleared 510(K)
- K021811UNIDRIVE II PLUS DISPOSABLE TUBING SET2Cleared 510(K)
- K020594DIEGO POWERED DISSECTOR AND DRILL SYSTEM2Cleared 510(K)
- K012456SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)2Cleared 510(K)
- K011321MODIFICATION TO XPS 3000 SYSTEM2Cleared 510(K)
- K011381HUMMER IV MICRODEBRIDER SYSTEM2Cleared 510(K)
- K003994KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES2Cleared 510(K)
- K002224XPS 3000 SYSTEM2Cleared 510(K)
- K002828XPS NITRO SYSTEM2Cleared 510(K)
- K992994TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;2Cleared 510(K)
- K990038HUMMER TRAK SYSTEM2Cleared 510(K)
- K983050PNEUMATIC CUTTER SYSTEM2Cleared 510(K)
- K983224XPS DRILL SYSTEM2Cleared 510(K)
- K981041SLT BIPOLAR SHEATH2Cleared 510(K)
- K981637INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY2Cleared 510(K)
- K974174ULTRABUR2Cleared 510(K)
- K972057POWERTREK INSTRUMENTS2Cleared 510(K)
- K972584STRYKER HUMMER II MICRODEBRIDER SYSTEM2Cleared 510(K)
- K973286ENT IRRIGATING PUMP (70327700)2Cleared 510(K)
- K972865PROMEX ENT TISSUE REMOVAL SYSTEM2Cleared 510(K)
- K972453XPS STRAIGHTSHOT MICRORESECTOR2Cleared 510(K)
- K970965MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)2Cleared 510(K)
- K964548APEX UNIVERSAL DRIVE SYSTEM2Cleared 510(K)
- K965080ANSPACH MICROMAX SYSTEM2Cleared 510(K)
- K963246TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT2Cleared 510(K)
- K962163MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL2Cleared 510(K)
- K961192IRRIGATION SYSTEM2Cleared 510(K)
- K954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES2Cleared 510(K)
- K954796MICRO-INGRESSOR HANDIPIECE2Cleared 510(K)
- K954715MICRO-PLANER HANDPIECE2Cleared 510(K)
- K952681STRYKER HUMMER II MICRODEBRIDER SYSTEM2Cleared 510(K)
- K951263INTRAARC DRIVE SYSTEM2Cleared 510(K)
- K950964KARL STORZ INTRA-HANDPIECES AND ACCESSORIES2Cleared 510(K)
- K945659BLACKSTAR(TM) STAR SYSTEM2Cleared 510(K)
- K943569STRYKER TOTAL PERFORMANCE SYSTEM2Cleared 510(K)
- K945438EDI-BUR MICRODRILL SYSTEMS2Cleared 510(K)
- K940016ELECTRIC SURGICAL DRILL2Cleared 510(K)
- K944476APEX UNIVERSAL DRIVE SYSTEM2Cleared 510(K)
- K943108MEDNEXT MICRO-DRILL2Cleared 510(K)
- K940710STRYKER MICRODEBRIDER SYSTEM2Cleared 510(K)
- K914346DRILL MODULES MODELS 2116/21172Cleared 510(K)
- K905800X-T AIR DRILL2Cleared 510(K)
- K873154TREACE MAGNUM OTO-TOOL SYSTEM2Cleared 510(K)
- K862807TREACE DRILL SYSTEM2Cleared 510(K)
- K854331MICRO-AIRE OTO/NEURO DRILL SYSTEM2Cleared 510(K)
- K854332MICRO-AIRE STAPES DRILL SYSTEM2Cleared 510(K)
- K841813TISSUE INTEGRATED PROSTHESIS DRILL2Cleared 510(K)
- K833875SHEA FOOTPLATE MICRODRILL2Cleared 510(K)
- K833874SHEA MIDDLE EAR MICRODRILL2Cleared 510(K)
- K831946SURGICAL DRILL-ELECTRIC-HANDPIECE2Cleared 510(K)
- K822008TORX OR TYPE MICRO MOTOR HANDPIECE2Cleared 510(K)
- K802463MICRO-SURGICAL POWER INSTRUMENT SYSTEM2Cleared 510(K)
- K792159FISCH DRILL SYSTEM2Cleared 510(K)
- K791407WOMED NICRO-CRAFT POWER SYSTEM2Cleared 510(K)
- K781418XOMED TRANSSPHENOIDAL HANDPIECE2Cleared 510(K)
- EWGLaser, Ent Microsurgical Carbon-Dioxide2Product Code
- EWQSaw, Surgical, Ent (Electric Or Pneumatic)1Product Code
- EWYMediastinoscope, Surgical2Product Code
- JEIClaw, Foreign Body, Bronchoscope (Non-Rigid)2Product Code
- JEJTubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)2Product Code
- JEKForceps, Biopsy, Bronchoscope (Rigid)2Product Code
- JELCurette, Biopsy, Bronchoscope (Rigid)2Product Code
- JYEChisel, Middle-Ear1Product Code
- JYFClamp, Ossicle Holding1Product Code
- JYGCurette, Ear1Product Code
- JYHExcavator, Ear1Product Code
- JYIGauge, Mastoid1Product Code
- JYJGauge, Measuring1Product Code
- JYLHook, Microsurgical Ear1Product Code
- JYMInserter, Myringotomy Tube1Product Code
- JYNInserter, Sacculotomy Tack1Product Code
- JYOKnife, Ear1Product Code
- JYPKnife, Myringotomy1Product Code
- JYQLoop, Wire1Product Code
- JYRNipper, Malleus1Product Code
- JYSPerforator, Ear-Lobe1Product Code
- JYTPick, Microsurgical Ear1Product Code
- JYWPress, Vein1Product Code
- JYXPunch, Attic1Product Code
- JYYRasp, Ear1Product Code
- JYZRod, Measuring Ear1Product Code
- JZARongeur, Mastoid1Product Code
- JZBScissors, Ear1Product Code
- JZCSearcher, Mastoid1Product Code
- JZDSnare, Ear1Product Code
- JZESpoon, Ear1Product Code
- JZFTube, Ear Suction1Product Code
- JZYKnife, Laryngeal1Product Code
- JZZSaw, Laryngeal1Product Code
- KAASet, Laryngeal Injection1Product Code
- KABTrocar, Laryngeal1Product Code
- KACTube, Laryngectomy1Product Code
- KADElevator, Ent1Product Code
- KAEForceps, Ent1Product Code
- KAHMicrorule, Ent1Product Code
- KAIMirror, Ent1Product Code
- KAJMobilizer, Ent1Product Code
- KAKProbe, Ent1Product Code
- KALRetractor, Ent1Product Code
- KAOCurette, Ethmoid1Product Code
- KAPCurette, Nasal1Product Code
- KAQGouge, Nasal, Ent1Product Code
- KARIrrigator, Sinus1Product Code
- KASKnife, Nasal1Product Code
- KATPerforator, Antrum1Product Code
- KAWPunch, Antrum1Product Code
- KAXPunch, Ethmoid1Product Code
- KAYPunch, Nasal1Product Code
- KAZRasp, Frontal-Sinus1Product Code
- KBARasp, Nasal1Product Code
- KBBRongeur, Nasal1Product Code
- KBCSaw, Nasal1Product Code
- KBDScissors, Nasal1Product Code
- KBESnare, Nasal1Product Code
- KBFTrephine, Sinus1Product Code
- KBGTrocar, Sinus1Product Code
- KBHAdenotome1Product Code
- KBIBougie, Eustachian1Product Code
- KBJCurette, Adenoid1Product Code
- KBKCurette, Salpingeal1Product Code
- KBLDepressor, Metal Tongue, Surgical1Product Code
- KBMDissector, Tonsil1Product Code
- KBNGag, Mouth1Product Code
- KBOGuillotine, Tonsil1Product Code
- KBPHook, Tonsil Suturing1Product Code
- KBQKnife, Tonsil1Product Code
- KBRNeedle, Tonsil Suturing1Product Code
- KBSPunch, Adenoid1Product Code
- KBTPunch, Tonsil1Product Code
- KBWScrew, Oral1Product Code
- KBXScrew, Tonsil1Product Code
- KBYSet, Filliform, Eustachian1Product Code
- KBZSnare, Tonsil1Product Code
- KCATonsillectome1Product Code
- KCBTube, Tonsil Suction1Product Code
- KCCBistoury, Tracheal1Product Code
- KCDBougie, Esophageal, Ent1Product Code
- KCFDilator, Esophageal, Ent1Product Code
- KCGDilator, Tracheal1Product Code
- KCHHook, Tracheal1Product Code
- KCITrocar, Tracheal1Product Code
- KTETrocar, Ent1Product Code
- KTFPunch, Ent1Product Code
- KTGKnife, Ent1Product Code
- KTIBronchoscope Accessory2Product Code
- KTRTube, Aspirating, Bronchoscope, Rigid2Product Code
- LJWTracheotome1Product Code
- LMSLaser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology2Product Code
- LRCInstrument, Ent Manual Surgical1Product Code
- LXRLaser, Microsurgical Argon, For Use In Otology2Product Code
- LYASplint, Intranasal Septal1Product Code
- MMOTray, Surgical, Ent1Product Code
- MQWTransilluminator, Fiber Optic1Product Code
- MXPBone Particle Collector1Product Code
- NLBTrocar, Tracheal, Laryngeal, Sinus, Reprocessed1Product Code
- NLEForceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed2Product Code
- NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed1Product Code
- NLZBur, Ent, Diamond Coated, Single Use, Reprocessed1Product Code
- OGREar, Nose, And Throat Surgical Tray1Product Code
- OGUPierced Ear/Entry Cleaning Tray1Product Code
- PNZEustachian Tube Balloon Dilation Device2Product Code
- QGKBalloon, Nasal Airway1Product Code
- QJLSplint, Intranasal Septal, Cber Led1Product Code
- QNWReprocessed Bronchoscope2Product Code
- QQHPowered Insertion System For A Cochlear Implant Electrode Array2Product Code
- OLLSeptal Stapler/Absorbable Staples2Product Code
- SBSLaryngeal Injection Set With Led Light1Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DTAD
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K121678
- 510(k) Type
- Traditional
- Applicant
- GYRUS ACMI, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/30/2012
- Days to Decision
- 84 days
- Submission Type
- Summary