Review Panel
Ear, Nose, Throat FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,803
- Product Codes (page)
- 26
- Latest Decision
- 2022-07-27
Clearances · page 3 of 39
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | Cochlear Americas | PFO | Class II | 2022-07-27 |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | ETD | Class II | 2022-07-27 |
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | Ambu A/S | EOQ | Class II | 2022-07-25 |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | KTI | Class II | 2022-07-20 |
| K213782 | Single-Use Video Bronchoscopes, Digital Controller | Micro-Tech (Nanjing) Co., Lts | EOQ | Class II | 2022-07-08 |
| K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | EOB | Class II | 2022-07-01 |
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | EWY | Class II | 2022-06-23 |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | EWO | Class II | 2022-06-22 |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | OTU Medical, Inc. | EOQ | Class II | 2022-06-16 |
| K220299 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2022-06-16 |
| K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | EOB | Class II | 2022-06-14 |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | ERL | Class II | 2022-05-26 |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | MIB | Class II | 2022-05-13 |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | NHB | Class II | 2022-05-05 |
| K220027 | Audion ET dilation system | Entellus Medical, Inc. | PNZ | Class II | 2022-04-12 |
| K220160 | PediGuard Threaded | Spineguard S.A. | PDQ | Class II | 2022-03-31 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | ETN | Class II | 2022-03-21 |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | KTI | Class II | 2022-03-08 |
| K213635 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2022-02-28 |
| K212886 | Broncoflex Agile, Broncoflex Vortex, Screeni | Axess Vision Technology | EOQ | Class II | 2022-02-16 |
| K212774 | VenSure LightGuide | Intersect Ent. | LRC | Class I | 2022-02-04 |
| K213424 | Jabra Enhance Plus | GN Hearing A/S | QDD | Class II | 2022-01-19 |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | ERL | Class II | 2022-01-19 |
| DEN210015 | Sunrise Sleep Disorder Diagnostic Aid | Sunrise | QRS | Class II | 2022-01-07 |
| K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | QDD | Class II | 2022-01-05 |
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | Karl Storz Endoscopy America | EOQ | Class II | 2021-12-29 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | LXB | Class II | 2021-12-16 |
| K211169 | Bronchoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | EOQ | Class II | 2021-11-24 |
| K211894 | Trachealator | Disa Medinotec | KTI | Class II | 2021-11-24 |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | EOQ | Class II | 2021-11-03 |
| K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | LYA | Class I | 2021-10-27 |
| K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | Pentax of America, Inc. | EOQ | Class II | 2021-10-21 |
| DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories | Iotamotion, Inc. | QQH | Class II | 2021-10-01 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | LXB | Class II | 2021-09-29 |
| K212667 | Single Use Guide Sheath Kit-401, K-402 | Olympus Medical Systems Corp. | EOQ | Class II | 2021-09-22 |
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | Intuitive Surgical, Inc. | EOQ | Class II | 2021-08-26 |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | ETN | Class II | 2021-08-26 |
| K210841 | NuVent Eustachian Tube Dilation Balloon | Medtronic Xomed, Inc. | PNZ | Class II | 2021-08-16 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | LXB | Class II | 2021-08-10 |
| K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | Boston Scientific Corporation | EOQ | Class II | 2021-08-09 |
| K210379 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | EOQ | Class II | 2021-07-28 |
| K202727 | Peregrine Endoscopy System | 3nt Medical , Ltd. | EOB | Class II | 2021-07-23 |
| K211493 | Monarch Platform | Auris Health, Inc. | EOQ | Class II | 2021-07-09 |
| K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | Ambu A/S | EOQ | Class II | 2021-06-17 |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | Stryker Corporation | ERL | Class II | 2021-06-09 |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | EWY | Class II | 2021-05-11 |
| K211008 | Bose SoundControl Hearing Aids | Bose Corporation | QDD | Class II | 2021-05-05 |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | EOX | Class II | 2021-05-04 |
| K202987 | Rescue Pulmonary Grasping Forceps | Anrei Medical (Hangzhou) Co., Ltd. | EOQ | Class II | 2021-04-29 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | PDQ | Class II | 2021-03-17 |
| K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | QNW | Class II | 2021-03-11 |
| DEN200006 | ClearUP Sinus Relief | Tivic Health Systems, Inc. | QNU | Class II | 2021-03-05 |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | MAH | Class II | 2021-03-03 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | LXB | Class II | 2021-02-23 |
| K202346 | SPiN Vision Video Bronchoscope System | Veran Medical Technologies, Inc. | EOQ | Class II | 2021-02-19 |
| K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | EOX | Class II | 2021-02-18 |
| K201454 | DSG Connect Technology | Spineguard S.A. | PDQ | Class II | 2021-02-10 |
| K201300 | Airway Mobilescope | Olympus Medical Systems Corp. | EOQ | Class II | 2021-01-26 |
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 | Olympus Medical Systems Corp. | EOQ | Class II | 2021-01-21 |
| K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | EOQ | Class II | 2021-01-14 |
| K200609 | ENTity WiFi Video Nasopharyngoscope System | Optim, LLC | EOB | Class II | 2021-01-13 |
| K200342 | Single 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-804L | Olympus Medical Systems Corp. | EOQ | Class II | 2020-12-17 |
| K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed | LYA | Class I | 2020-12-08 |
| K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | EOQ | Class II | 2020-11-16 |
| K200886 | StimSite | Allotrope Medical, Inc. | ETN | Class II | 2020-11-10 |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | KARL STORZ Endoscopy-America, Inc. | ERL | Class II | 2020-10-22 |
| K202180 | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | Axess Vision Technology | EOQ | Class II | 2020-10-22 |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | LRC | Class I | 2020-10-15 |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | Med-El Elektromedizinische Geraete GmbH | PFO | Class II | 2020-10-09 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | LRC | Class I | 2020-08-27 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | LRC | Class I | 2020-08-26 |
| K200740 | HD Video Rhino Laryngoscope | KARL STORZ Endoscopy-America, Inc. | EOB | Class II | 2020-08-11 |
| K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | Pentax of America, Inc. | EOQ | Class II | 2020-07-30 |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-El Elektromedizinische Geraete GmbH | PFO | Class II | 2020-07-29 |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | MIB | Class II | 2020-07-20 |
| K201146 | Ion Endoluminal System | Intuitive Surgical, Inc. | EOQ | Class II | 2020-06-26 |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | KLW | Class II | 2020-06-19 |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | ETD | Class II | 2020-06-05 |
| K200532 | StarPore | Anatomics Pty, Ltd. | JOF | Class II | 2020-06-02 |
| K200397 | Single Use Biopsy Forceps FB-456D | Olympus Medical Systems Corp. | EOQ | Class II | 2020-04-24 |
| K193534 | Monarch Platform | Auris Health, Inc. | EOQ | Class II | 2020-04-15 |
| K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | KTI | Class II | 2020-03-18 |
| K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | EOQ | Class II | 2020-03-06 |
| K192305 | Colibri Endoscopy System | 3nt Medical , Ltd. | EOB | Class II | 2020-02-27 |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | KLW | Class II | 2020-02-20 |
| K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2020-02-13 |
| K182927 | Pulmonary Cytology Brush | Hobbs Medical, Inc. | BTG | Class II | 2020-02-07 |
| K192090 | CMOS Video Rhino-Laryngoscope SSU | Karl Storz SE & CO. KG | EOB | Class II | 2020-01-27 |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | EOX | Class II | 2020-01-24 |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | EOQ | Class II | 2020-01-16 |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | LRC | Class I | 2020-01-03 |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | Interscope, Inc. | ERL | Class II | 2019-12-13 |
| K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | KTI | Class II | 2019-12-10 |
| K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | EOQ | Class II | 2019-11-26 |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Cochlear Americas | PFO | Class II | 2019-11-15 |
| K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | NHB | Class II | 2019-11-10 |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | PDQ | Class II | 2019-10-18 |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) | Med-El Elektromedizinische Geraete GmbH | PFO | Class II | 2019-09-18 |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | Olympus Medical Systems Corp. | EOB | Class II | 2019-09-06 |
| K191102 | Precision S 4K Sinuscope | Stryker | EOB | Class II | 2019-09-06 |
3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.