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
- K252045Ion Endoluminal System (IF1000)2Cleared 510(K)
- K251894Himaging Bronchscope System2Cleared 510(K)
- K252528Ion Endoluminal System (IF1000)2Cleared 510(K)
- K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)2Cleared 510(K)
- K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)2Cleared 510(K)
- K250232Vathin® Video Bronchoscope System2Cleared 510(K)
- K250862EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)2Cleared 510(K)
- K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-80002Cleared 510(K)
- K250118Disposable Balloon Catheter B5-2C2Cleared 510(K)
- K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)2Cleared 510(K)
- K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US2Cleared 510(K)
- K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.2Cleared 510(K)
- K243541LumiRex Bronchoscope2Cleared 510(K)
- K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))2Cleared 510(K)
- K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)2Cleared 510(K)
- K242324DUTAU-NOVATECH®2Cleared 510(K)
- K243219MONARCH™ Platform (MON-000008)2Cleared 510(K)
- K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL2Cleared 510(K)
- K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)2Cleared 510(K)
- K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)2Cleared 510(K)
- K242070Ion Endoluminal System (IF 1000)2Cleared 510(K)
- K232601BroncTru™ Transbronchial Access Tool2Cleared 510(K)
- K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box2Cleared 510(K)
- K232038BioStar Single Use Transbronchial Aspiration Needle2Cleared 510(K)
- K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)2Cleared 510(K)
- K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)2Cleared 510(K)
- K231107Bronchoscope System2Cleared 510(K)
- K240075FUJIFILM Endoscope Model EB-710XT2Cleared 510(K)
- K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U2Cleared 510(K)
- K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock2Cleared 510(K)
- K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance2Cleared 510(K)
- K232984Ion Endoluminal System (IF1000)2Cleared 510(K)
- K231521Broncho Videoscope System2Cleared 510(K)
- K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set2Cleared 510(K)
- K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 22Cleared 510(K)
- K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH11002Cleared 510(K)
- K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance2Cleared 510(K)
- K223836Vathin® Video Bronchoscope System2Cleared 510(K)
- K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope2Cleared 510(K)
- K222910Bronchoscope System2Cleared 510(K)
- K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)2Cleared 510(K)
- K223144Galaxy System2Cleared 510(K)
- K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set2Cleared 510(K)
- K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System2Cleared 510(K)
- K220957FUJIFILM Endoscope Model EB-710P2Cleared 510(K)
- K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V2Cleared 510(K)
- K221302Recon Steerable Sheath2Cleared 510(K)
- K222014EXALT Model B Single-Use Bronchoscope2Cleared 510(K)
- K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 22Cleared 510(K)
- K213782Single-Use Video Bronchoscopes, Digital Controller2Cleared 510(K)
- K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System2Cleared 510(K)
- K220299Ion Endoluminal System (IF1000)2Cleared 510(K)
- K213635Vathin Video Bronchoscope System2Cleared 510(K)
- K212886Broncoflex Agile, Broncoflex Vortex, Screeni2Cleared 510(K)
- K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S)2Cleared 510(K)
- K211169Bronchoscope System2Cleared 510(K)
- K211947GlideScope BFlex 2.8 Single-Use Bronchoscope2Cleared 510(K)
- K210928PENTAX Medical Video Bronchoscope EB11-J102Cleared 510(K)
- K212667Single Use Guide Sheath Kit-401, K-4022Cleared 510(K)
- K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)2Cleared 510(K)
- K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor2Cleared 510(K)
- K210379Broncho Videoscope System2Cleared 510(K)
- K211493Monarch Platform2Cleared 510(K)
- K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.82Cleared 510(K)
- K202987Rescue Pulmonary Grasping Forceps2Cleared 510(K)
- K202346SPiN Vision Video Bronchoscope System2Cleared 510(K)
- K201300Airway Mobilescope2Cleared 510(K)
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P1902Cleared 510(K)
- K200702EasyPath RF Introducer Sheath2Cleared 510(K)
- K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L2Cleared 510(K)
- K202370Ion Endoluminal System2Cleared 510(K)
- K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 300300012Cleared 510(K)
- K200678PENTAX Medical Video Bronchoscope EB-J10 Series2Cleared 510(K)
- K201146Ion Endoluminal System2Cleared 510(K)
- K200397Single Use Biopsy Forceps FB-456D2Cleared 510(K)
- K193534Monarch Platform2Cleared 510(K)
- K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR2Cleared 510(K)
- K191828Vathin Video Bronchoscope System2Cleared 510(K)
- K193488GlideScope BFlex 3.8 Single-Use Bronchoscope2Cleared 510(K)
- K192367Ion Endoluminal System2Cleared 510(K)
- K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U2Cleared 510(K)
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT1902Cleared 510(K)
- K183607FUJIFILM Bronchoscope2Cleared 510(K)
- K191948GlideScope BFlex 5.8 Single-Use Bronchoscope2Cleared 510(K)
- K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus2Cleared 510(K)
- K182253FUJIFILM Video Bronchoscopes2Cleared 510(K)
- K183085CoreDx™ Pulmonary Mini-Forceps2Cleared 510(K)
- K182825FUJIFILM Ultrasonic Endoscope2Cleared 510(K)
- K182188Ion Endoluminal System ; Flexision Biopsy Needle2Cleared 510(K)
- K183256GlideScope BFlex Single-Use Bronchoscope System2Cleared 510(K)
- K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D2Cleared 510(K)
- K172955LungVision Tool2Cleared 510(K)
- K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor2Cleared 510(K)
- K173760Monarch Endoscopy Platform (Monarch Platform)2Cleared 510(K)
- K163377Captura Disposable Bronchoscope Biopsy Forceps2Cleared 510(K)
- K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope2Cleared 510(K)
- K171291FUJIFILM Bronchoscope Model EB-530P2Cleared 510(K)
- K171492B7 2C Occlusion Balloon2Cleared 510(K)
- K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga2Cleared 510(K)
- K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle2Cleared 510(K)
- K162611PeriFLEX2Cleared 510(K)
- K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor2Cleared 510(K)
- K152319Auris Robotic Endoscopy System (ARES)2Cleared 510(K)
- K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)2Cleared 510(K)
- K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle2Cleared 510(K)
- K143727PENTAX Medical EKP-i5010 Video Processor with EB Family2Cleared 510(K)
- K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved2Cleared 510(K)
- K150280PulmoVia Working Channel2Cleared 510(K)
- K142839GenCut Core Biopsy System2Cleared 510(K)
- K142909Flexible 19G EBUS Needle2Cleared 510(K)
- K141366VIDEO BRONCHOSCOPE SYSTEM2Cleared 510(K)
- K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS2Cleared 510(K)
- K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)2Cleared 510(K)
- K130845AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW2Cleared 510(K)
- K131234LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)2Cleared 510(K)
- K131401BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER2Cleared 510(K)
- K121959EVIS EXERA III VIDEO SYSTEM2Cleared 510(K)
- K122535FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H2Cleared 510(K)
- K121035FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US2Cleared 510(K)
- K091768VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES2Cleared 510(K)
- K091250DIAGNOSTIC CATHETER SYSTEM2Cleared 510(K)
- K090853YIELD TISSUE SAMPLER2Cleared 510(K)
- K082720TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y00052Cleared 510(K)
- K081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK2Cleared 510(K)
- K071530KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM2Cleared 510(K)
- K071473MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 22Cleared 510(K)
- K061313EVIS EXERA 180 SYSTEM2Cleared 510(K)
- K060243OLYMPUS GUIDE SHEATH, MODEL XBO1-836-132Cleared 510(K)
- K050907FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P2Cleared 510(K)
- K050220EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC2Cleared 510(K)
- K040940BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM2Cleared 510(K)
- K040018EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 64122Cleared 510(K)
- K033225EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K031966ENK FIBEROPTIC ATOMIZER SET2Cleared 510(K)
- K022446MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C2Cleared 510(K)
- K023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES2Cleared 510(K)
- K024165DUAL-LUMEN CATHETER2Cleared 510(K)
- K023376EB-1830T3, VIDEO BRONCHOSCOPE2Cleared 510(K)
- K022546HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES2Cleared 510(K)
- K021344B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM2Cleared 510(K)
- K013731GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/032Cleared 510(K)
- K013111EXHALE PROBE2Cleared 510(K)
- K012073OLYMPUS SPRAY CATHETER PW-6C-12Cleared 510(K)
- K011267EXHALE RF PROBE2Cleared 510(K)
- K993900COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-1152Cleared 510(K)
- K990547PILLING WECK SURGICAL Y STENT FORCEPS2Cleared 510(K)
- K983878CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE2Cleared 510(K)
- K984157MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE2Cleared 510(K)
- K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT2Cleared 510(K)
- K983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT2Cleared 510(K)
- K982983LSVP INTERNATIONAL BIOPSY FORCEPS2Cleared 510(K)
- K981543OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K980046BRONCHIAL CATHETER SYSTEM2Cleared 510(K)
- K974642COMBICATH CATHETER2Cleared 510(K)
- K970107INTUBATION ENDOSCOPE AND INTRODUCER SHEATH2Cleared 510(K)
- K963795VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH2Cleared 510(K)
- K963252TBAN2Cleared 510(K)
- K963033BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES2Cleared 510(K)
- K962901OLYMPUS B5-2C/B7-2C BALLOON CATHETER2Cleared 510(K)
- K962485OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)2Cleared 510(K)
- K962533OLYPUS FG SERIES GRASPING FORCEPS2Cleared 510(K)
- K962380OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)2Cleared 510(K)
- K962367OLYMPUS BASKET GRASPERS2Cleared 510(K)
- K962378OLYMPUS FG-45/46-1 GRASPING FORCEPS2Cleared 510(K)
- K962555OLYMPUS FB SERIES BIOPSY FORCEPS2Cleared 510(K)
- K962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE2Cleared 510(K)
- K961178KARL STORZ INTUBATION FIBERSCOPE2Cleared 510(K)
- K960880MILL-ROSE BLIND MICROBIOLOGY BRUSH2Cleared 510(K)
- K960791KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS2Cleared 510(K)
- K954797KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY2Cleared 510(K)
- K945268OPTUS BRONCHOSCOPES2Cleared 510(K)
- K954707BRONCHOSCOPE2Cleared 510(K)
- K954125SAUER ENDOSCOPE GUIDE AND INTUBATION AID2Cleared 510(K)
- K953596DISTENDING DIVERTICULOSCOPE2Cleared 510(K)
- K950925JEDMED LARYNGEAL SCOPE2Cleared 510(K)
- K952081KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING2Cleared 510(K)
- K951826KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE2Cleared 510(K)
- K951199FB-18X, FIBER BRONCHOSCOPE2Cleared 510(K)
- K950965KARL STORZ STENT APPLICATOR FORCEPS2Cleared 510(K)
- K951051RITE-BITE BIOPSY FORCEPS2Cleared 510(K)
- K950786OLYMPUS BIOPSY FORCEPS MODEL FB-442Cleared 510(K)
- K950636OLYMPUS DISPOSABLE BIOPSY FORCEPS2Cleared 510(K)
- K93144211274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE2Cleared 510(K)
- K944976BRONCHOSCOPE,NON-RIGID2Cleared 510(K)
- K944649MILL-ROSE HARRELL BRONCHIAL BRUSH2Cleared 510(K)
- K944650WANG BRONCHIAL NEEDLE BRUSH2Cleared 510(K)
- K943700KARL STORZ BRONCHOSCOPE ACCESSORIES2Cleared 510(K)
- K942388TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE2Cleared 510(K)
- K941264RICHARD ROD LENS LARYNGOSCOPE2Cleared 510(K)
- K941161FLEXIBLE GRASPING FORCEPS2Cleared 510(K)
- K940521MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER2Cleared 510(K)
- K941158FLEXIBLE BIOPSY CUP FORCEPS2Cleared 510(K)
- K934920VB-1830/VB-1530, VIDEO BRONCHOSCOPE2Cleared 510(K)
- K933433MODIFIED BRONCHOSCOPE AND ACCESSORIES2Cleared 510(K)
- K931154EVIS 200 SYSTEM2Cleared 510(K)
- K922204MILL-ROSE PULMONARY FORCEPS2Cleared 510(K)
- K926430CANNULATED BIOPSY FORCEPS2Cleared 510(K)
- K923847DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS2Cleared 510(K)
- K922937FLEXIBLE FIBER OPTIC ENDOSCOPE2Cleared 510(K)
- K921393IMAGICA MICRO-ENDOSCOPE2Cleared 510(K)
- K915816BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY2Cleared 510(K)
- K920025OLYMPUS DISPOSABLE SUCTION VALVE2Cleared 510(K)
- K914181WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE2Cleared 510(K)
- K910536PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER2Cleared 510(K)
- K911922BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-22002Cleared 510(K)
- K911412OLYMPUS DISPOSABLE BIOPSY VALVE2Cleared 510(K)
- K910423BRONCHOSCOPE BF-N202Cleared 510(K)
- K895948PORT-O-SCOPE(TM)2Cleared 510(K)
- K896146BIOPSY FORCEPS, (NON-RIGID)2Cleared 510(K)
- K893006EXMOOR BITE BUFFER2Cleared 510(K)
- K895415BIOPSY FORCEPS2Cleared 510(K)
- K892687CANNULATED BIOPSY FORCEPS2Cleared 510(K)
- K870063CO2 LASER BRONCHOSCOPE SET2Cleared 510(K)
- K862835CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE2Cleared 510(K)
- K854414DUMON/HARRELL2Cleared 510(K)
- K854581MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-502Cleared 510(K)
- K844834MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-12Cleared 510(K)
- K833483ENDOSCOPIC COUPLER2Cleared 510(K)
- K832492BRONCHO FIBERSCOPE FB-19C2Cleared 510(K)
- K832449LARYNGOTELESCOPE CURVED MLC-12Cleared 510(K)
- K832010BRONCHO-FIBERSCOPE2Cleared 510(K)
- K831240LASER BRONCHOSCOPE2Cleared 510(K)
- K822844PENTAX BRONCHOFIBERSCOPE #FB-19E2Cleared 510(K)
- K822257VARIOUS TYPES OF LIGHT SOURCE HANDLES2Cleared 510(K)
- K822180RIGID FIBEROPTIC ENDOSCOPES2Cleared 510(K)
- K822136LASER BRONCHOSCOPE2Cleared 510(K)
- K811218ACMI ASPIRATOR KIT #88082Cleared 510(K)
- K811059PENTAX BRONCHOFIBERSCOPE #FB-15A2Cleared 510(K)
- K811181MODEL FBS-1, FLEXIBLE BRONCHOSCOPE2Cleared 510(K)
- K792342PENTAX BROCHOFIBERSCOPE MODEL FB-17D,2Cleared 510(K)
- K792267PENTEX BRONCHOFIBERSCOPE MODEL FB-17A2Cleared 510(K)
- K7705003 PORT LUER2Cleared 510(K)
- K760171FIBERBRONCHOSCOPE (PENTAX FB-17A)2Cleared 510(K)
- 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
- 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
Monarch Platform
- Page Type
- Cleared 510(K)
- 510(k) Number
- K211493
- 510(k) Type
- Special
- Applicant
- Auris Health, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/9/2021
- Days to Decision
- 57 days
- Submission Type
- Summary