Review Panel
Ear, Nose, Throat FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,803
- Product Codes (page)
- 30
- Latest Decision
- 2024-07-10
Clearances · page 2 of 39
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K232177 | Lightin System, Lightin, Lightin Generator | Solmedix Co., Ltd. | SBS | Class I | 2024-07-10 |
| K234095 | OtoNova/OtoNova Pro | Otodynamics | EWO | Class II | 2024-06-21 |
| K232601 | BroncTru Transbronchial Access Tool | Broncus Medical, Inc. | EOQ | Class II | 2024-05-31 |
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated | KHJ | Class II | 2024-05-24 |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | ETD | Class II | 2024-05-20 |
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | MIX | Class II | 2024-05-03 |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | Medimaging Integrated Solution, Inc (Miis) | EOQ | Class II | 2024-05-01 |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | EOB | Class II | 2024-04-26 |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. | EOQ | Class II | 2024-04-26 |
| K240155 | Cochlear Osia System | Cochlear Americas | PFO | Class II | 2024-04-18 |
| K232999 | Lyric4 Hearing Aid | Sonova AG | ESD | Class I | 2024-04-11 |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | MacroLux Medical Technology Co., Ltd. | EOQ | Class II | 2024-04-05 |
| K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2024-04-03 |
| K233569 | SeptAlign | Spirair, Inc. | NHB | Class II | 2024-03-22 |
| K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | QUH | Class II | 2024-03-15 |
| K240430 | Otoport Pro | Otodynamics, Ltd. | EWO | Class II | 2024-03-15 |
| K233958 | hekaDrill | Zethon, Ltd. | ERL | Class II | 2024-03-14 |
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | KLW | Class II | 2024-02-27 |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | ETD | Class II | 2024-02-16 |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. | EOQ | Class II | 2024-02-15 |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S | QUH | Class II | 2024-02-09 |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | EOQ | Class II | 2024-02-07 |
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | EOX | Class II | 2024-01-19 |
| K232860 | PENTAX 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-J10U | Pentax of America, Inc. | EOQ | Class II | 2024-01-18 |
| K231970 | PENTAX 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-Dock | Pentax of America, Inc. | EOQ | Class II | 2024-01-12 |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Ambu A/S | EOQ | Class II | 2024-01-04 |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | ETN | Class II | 2023-12-21 |
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2023-12-18 |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | PNZ | Class II | 2023-12-13 |
| DEN230045 | Sonu | Sound Health Systems, Inc. | QZC | Class II | 2023-12-04 |
| K231473 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | QNW | Class II | 2023-11-28 |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | ETD | Class II | 2023-11-24 |
| K231818 | METIC- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. | KTI | Class II | 2023-11-15 |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | EOQ | Class II | 2023-11-14 |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | EWO | Class II | 2023-10-27 |
| K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | QUH | Class II | 2023-10-26 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | ETN | Class II | 2023-10-26 |
| K223911 | Lumen 155-SF | Intricon Corporation | QDD | Class II | 2023-10-17 |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | ETN | Class II | 2023-10-06 |
| K221052 | Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. | QUH | Class II | 2023-09-25 |
| K230778 | EndoCore | Praxis Medical, LLC | KTI | Class II | 2023-09-25 |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | EOQ | Class II | 2023-09-20 |
| K223848 | Intrisound Tuned Lumen® 155 Hearing Aids | Tuned , Ltd. | QUH | Class II | 2023-09-08 |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | ETN | Class II | 2023-08-30 |
| K231204 | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App | Cochlear | PFO | Class II | 2023-08-18 |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | NHB | Class II | 2023-08-17 |
| K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Ambu A/S | EOQ | Class II | 2023-08-10 |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | Atmos Medizintechnik GmbH & Co. KG | EOB | Class II | 2023-08-03 |
| K223542 | TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH | PNZ | Class II | 2023-08-03 |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | EOB | Class II | 2023-07-28 |
| DEN220047 | Galen ES Cooperative Surgical Assistant Platform, Galen ES | Galen Robotics | QXG | Class II | 2023-07-19 |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | KLW | Class II | 2023-06-30 |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG | QUH | Class II | 2023-06-16 |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corporation | EOQ | Class II | 2023-06-15 |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | EOB | Class II | 2023-06-14 |
| K223299 | Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance | Ambu A/S | EOQ | Class II | 2023-06-01 |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System | Fiagon GmbH | PNZ | Class II | 2023-05-26 |
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | LRC | Class I | 2023-05-25 |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2023-05-15 |
| K222106 | Waypoint GPS | Waypoint Orthopedics, Inc. | QWP | Class II | 2023-05-12 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | KTI | Class II | 2023-05-11 |
| K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | EOQ | Class II | 2023-05-03 |
| K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | EOQ | Class II | 2023-04-11 |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | LYA | Class I | 2023-03-22 |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty) , Ltd. | QUH | Class II | 2023-03-14 |
| DEN210033 | Lenire Tinnitus Treatment Device | Neuromod Devices Limited | QVN | Class II | 2023-03-06 |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | Boston Scientific Corporation | EOQ | Class II | 2023-03-02 |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | KTI | Class II | 2023-03-01 |
| K223144 | Galaxy System | Noah Medical Corp. | EOQ | Class II | 2023-03-01 |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | EOX | Class II | 2023-02-24 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | PDQ | Class II | 2023-02-10 |
| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | MIB | Class II | 2023-02-03 |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | KLW | Class II | 2023-02-01 |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | ETN | Class II | 2023-01-27 |
| K223782 | Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set | Ambu A/S | EOQ | Class II | 2023-01-12 |
| K221125 | SilentCloud | Aureliym GmbH | KLW | Class II | 2023-01-04 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | EOB | Class II | 2022-12-28 |
| K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | MIB | Class II | 2022-12-23 |
| K222262 | Sunrise | Sunrise SA | QRS | Class II | 2022-12-22 |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | Pentax of America, Inc. | EOQ | Class II | 2022-12-21 |
| K221698 | Eargo 5 , Eargo 6 | Eargo, Inc. | QUH | Class II | 2022-12-21 |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | EOX | Class II | 2022-12-02 |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | EOB | Class II | 2022-11-18 |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | Pentax of America, Inc. | EOB | Class II | 2022-11-16 |
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | EMX | Class I | 2022-11-14 |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | ETN | Class II | 2022-11-11 |
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | EOQ | Class II | 2022-11-10 |
| K221184 | ORiGO System | Bien-Air Surgery SA | ERL | Class II | 2022-11-02 |
| K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | QUH | Class II | 2022-10-30 |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | EOX | Class II | 2022-10-26 |
| K200073 | AugMENTA Penile Implant | Augmenta, LLC | MIB | Class II | 2022-09-30 |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | Olympus Medical Systems Corp. | EOQ | Class II | 2022-09-26 |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | PDQ | Class II | 2022-09-23 |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | Olympus Medical Systems Corp. | EOB | Class II | 2022-09-19 |
| DEN220025 | Phagenyx System | Phagenesis Limited | QQG | Class II | 2022-09-16 |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | KTI | Class II | 2022-08-25 |
| K221302 | Recon Steerable Sheath | Serpex Medical, Inc. | EOQ | Class II | 2022-08-15 |
| K220403 | Vibe SF Self-Fitting Hearing Aid | Wsaud A/S | QDD | Class II | 2022-08-12 |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aids | Mdhearingaid | QDD | Class II | 2022-08-04 |
| K222014 | EXALT Model B Single-Use Bronchoscope | Boston Scientific Corporation | EOQ | Class II | 2022-07-28 |
3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.