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
- K234096MonoStereo2Cleared 510(K)
- K232435Rhinolaryngoscope system2Cleared 510(K)
- K232015ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)2Cleared 510(K)
- K222587PatCom Distal Chip Endoscope2Cleared 510(K)
- K230536Single-use Flexible Rhinolaryngoscope; Digital Video Monitor2Cleared 510(K)
- K221660RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP2Cleared 510(K)
- K221581Single-Use Flexible Rhinolaryngoscope2Cleared 510(K)
- K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J102Cleared 510(K)
- K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V32Cleared 510(K)
- K214050ENT Nasopharyngoscope and Accessories2Cleared 510(K)
- K220004Zsquare ENT-Flex Endoscope2Cleared 510(K)
- K202727Peregrine Endoscopy System2Cleared 510(K)
- K200609ENTity WiFi Video Nasopharyngoscope System2Cleared 510(K)
- K200740HD Video Rhino Laryngoscope2Cleared 510(K)
- K192305Colibri Endoscopy System2Cleared 510(K)
- K192090CMOS Video Rhino-Laryngoscope SSU2Cleared 510(K)
- K191102Precision S 4K Sinuscope2Cleared 510(K)
- K183416Rhino-Laryngo Videoscope Olympus ENF-VT32Cleared 510(K)
- K190972Ambu aScope 4 RhinoLaryngo Intervention2Cleared 510(K)
- K183691PENTAX Medical ENT Video Imaging System2Cleared 510(K)
- K191080Ambu aScope 4 RhinoLaryngo Slim2Cleared 510(K)
- K182186CMOS Video-Rhino-Laryngoscope System2Cleared 510(K)
- K182102RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V42Cleared 510(K)
- K182846PENTAX Medical EPK-3000 Video Imaging System2Cleared 510(K)
- K181286Ambu aScope RLS Slim2Cleared 510(K)
- K181240Rhino-Laryngo Fiberscope Olympus ENF-GP22Cleared 510(K)
- K171011PENTAX Medical VIVIDEO ENT Videoscope Solution2Cleared 510(K)
- K173855Sharpsite AC Rigid Endsocope2Cleared 510(K)
- K172156PENTAX Medical EPK-3000 Video Imaging System2Cleared 510(K)
- K171402KARL STORZ Slim Nasopharyngolaryngoscope2Cleared 510(K)
- K170453Medrobotics Flex Robotic System2Cleared 510(K)
- K161298ShenDa Sinuscope2Cleared 510(K)
- K170285AED Sinuscope2Cleared 510(K)
- K162151PENTAX Medical ENT Video Imaging System2Cleared 510(K)
- K162410TIPCAM 1S 3D System2Cleared 510(K)
- K1629163NT endoscopy system2Cleared 510(K)
- K153701ULYSS Multi View Sinuscope2Cleared 510(K)
- K153009ULTRA Telescopes2Cleared 510(K)
- K152531InstaClear Lens Cleaner2Cleared 510(K)
- K150776Medrobotics Flex System2Cleared 510(K)
- K143673CMOS Video Nasopharyngoscope System2Cleared 510(K)
- K142249SCHOELLY SINUSCOPE2Cleared 510(K)
- K131323ECLERIS SINUSCOPE2Cleared 510(K)
- K132433ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE2Cleared 510(K)
- K132009CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM2Cleared 510(K)
- K103467CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM2Cleared 510(K)
- K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE2Cleared 510(K)
- K102733VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR2Cleared 510(K)
- K102366FINESS ENDOSCOPE2Cleared 510(K)
- K100577ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE2Cleared 510(K)
- K100125VISION SCIENCES FLEXIBLE ENT SCOPE2Cleared 510(K)
- K083553NASO-LARYNGO-PHARYNGOSCOPE2Cleared 510(K)
- K080740CLEARVIEW ENDOSCOPE COVER2Cleared 510(K)
- K082667VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)2Cleared 510(K)
- K082569ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE2Cleared 510(K)
- K080622ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 0061052Cleared 510(K)
- K072387KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES2Cleared 510(K)
- K072073VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR2Cleared 510(K)
- K070580NASOPHARYNGOSCOPE, BRONCHOSCOPE2Cleared 510(K)
- K070752KSEA MINIATURE ENDOSCOPE, MODEL 115652Cleared 510(K)
- K063078MICROENDOSCOPE2Cleared 510(K)
- K061663ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES2Cleared 510(K)
- K052452VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT2Cleared 510(K)
- K050972VISION-SCIENCES ENT-3000 SCOPE2Cleared 510(K)
- K040984VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE2Cleared 510(K)
- K032822ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-02Cleared 510(K)
- K030857MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES2Cleared 510(K)
- K031648VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V2Cleared 510(K)
- K031790SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING2Cleared 510(K)
- K030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE2Cleared 510(K)
- K023004LFRE INDIRECT LARYNGOSCOPE2Cleared 510(K)
- K024095MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM2Cleared 510(K)
- K012543VISION SCIENCES ENDOSHEATH SYSTEM2Cleared 510(K)
- K021073VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V2Cleared 510(K)
- K020599MTP CLEARVISION DISPOSABLE TUBING SET2Cleared 510(K)
- K013838KSEA CLEARVISION LENS IRRIGATION SYSTEM2Cleared 510(K)
- K013591XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K011869XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K003830ENT ENDOSCOPES2Cleared 510(K)
- K002214SINUSCOPE AND BACCESSORIES2Cleared 510(K)
- K002700KSEA UNIMAT 122Cleared 510(K)
- K992526FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE2Cleared 510(K)
- K991560NASO-LARYNGO-PHARYNGOSCOPE2Cleared 510(K)
- K990354ENDOSHEATH2Cleared 510(K)
- K990213HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET2Cleared 510(K)
- K984369DCI ENDOSCOPE2Cleared 510(K)
- K983123POC ENT ENDOSCOPE - SINUSCOPE2Cleared 510(K)
- K982594ENDO-SCRUB/ENDO-SCRUB 22Cleared 510(K)
- K981751SINUSCOPE AND ACCESSORIES2Cleared 510(K)
- K981458KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 1102Cleared 510(K)
- K972450FLEXTIP GRASPER2Cleared 510(K)
- K971375GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE2Cleared 510(K)
- K972855KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES2Cleared 510(K)
- K971995MEDIVISION SINOSCOPE2Cleared 510(K)
- K965233SHARPSITE AC2Cleared 510(K)
- K970247SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE2Cleared 510(K)
- K962116GALILEO ENDOSCOPES2Cleared 510(K)
- K963757IRRIGATION/SUCTION HANDLE AND SHEATH2Cleared 510(K)
- K963426KARL STORZ CONTACT MICRO-LARYNGOSCOPES2Cleared 510(K)
- K962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)2Cleared 510(K)
- K962898KSEA UNIMAT PLUS2Cleared 510(K)
- K962396KSEA BIPOLAR GOAGULATING FORCEPS2Cleared 510(K)
- K950809VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES2Cleared 510(K)
- K961591DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE2Cleared 510(K)
- K960876FIVE STAR BRONCHOSCOPE2Cleared 510(K)
- K955560TREBAY SCOPE IRRIGATED CLEARING SLEEVE2Cleared 510(K)
- K942265FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH2Cleared 510(K)
- K953771OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS2Cleared 510(K)
- K954348GLANZ CARCINOMA GAUGE, KSEA2Cleared 510(K)
- K954336ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)2Cleared 510(K)
- K953888TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE2Cleared 510(K)
- K940317SINUSCOPE2Cleared 510(K)
- K951249CITATION SINUSCOPE2Cleared 510(K)
- K951196FNL-10P, FIBER NASOPARHYNGOSCOPE2Cleared 510(K)
- K951201KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE2Cleared 510(K)
- K940028ENDOSCOPE SHEATH2Cleared 510(K)
- K945081TRANSTYMPANIC ENDOSCOPE2Cleared 510(K)
- K950603KARL STORZ VISCOUS FLUID INJECTION SET2Cleared 510(K)
- K950334KARL STORZ TELE-SCRUB2Cleared 510(K)
- K950338KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS2Cleared 510(K)
- K944861KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE2Cleared 510(K)
- K946011ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM2Cleared 510(K)
- K946148KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES2Cleared 510(K)
- K944671VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})2Cleared 510(K)
- K944670JARIT RECOMMENDED SINUS INSTRUMENTS2Cleared 510(K)
- K944656OPTUS SINUSCOPES AND ACCESSORIES2Cleared 510(K)
- K945788KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES2Cleared 510(K)
- K945381NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES2Cleared 510(K)
- K944072OLYMPUS NASAL AND SINUS ENDOSCOPES2Cleared 510(K)
- K944797KARL STORZ INSULATED CANNULAE, SUCTION TUBES2Cleared 510(K)
- K944298KARL STORZ INSULATED SCISSORS2Cleared 510(K)
- K944186SINUSCOPE2Cleared 510(K)
- K944296KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR2Cleared 510(K)
- K943665NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS2Cleared 510(K)
- K943816TROCARS,CANNULAE, SHEATHS2Cleared 510(K)
- K943074FORCEPS, PUNCHES, SCISSORS2Cleared 510(K)
- K933672XOMED-TREACE SCOPESHEATH2Cleared 510(K)
- K941565JARIT RECOMMENDED SINUS INSTRUMENTS2Cleared 510(K)
- K936257ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.32Cleared 510(K)
- K934422NASOPHARYNGOSCOPE2Cleared 510(K)
- K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPE2Cleared 510(K)
- K933247PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS2Cleared 510(K)
- K932988ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY2Cleared 510(K)
- K930931NASAL/PARANASAL ENDOSCOPE2Cleared 510(K)
- K925421ENDOSHEATH2Cleared 510(K)
- K921244DISPOSABLE PROTECTIVE SHEATH2Cleared 510(K)
- K920439OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE2Cleared 510(K)
- K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP22Cleared 510(K)
- K902683SCOPESCRUBBER(TM)2Cleared 510(K)
- K900176ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES2Cleared 510(K)
- K896297FLEXIBLE NASOPHARYNGOSCOPE2Cleared 510(K)
- K895245FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE2Cleared 510(K)
- K882744EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM2Cleared 510(K)
- K874215ENDOSCOPES FOR SINUS SURGERY2Cleared 510(K)
- K864821AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-22Cleared 510(K)
- 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
- 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
PENTAX Medical EPK-3000 Video Imaging System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182846
- 510(k) Type
- Special
- Applicant
- PENTAX of America, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/9/2019
- Days to Decision
- 92 days
- Submission Type
- Summary