Decisions49
Applicants42
Latest2026-09-23
FDA decided 49 premarket notifications (510(k)s) for ear, nose, throat devices from 42 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.
| Decided | Applicant | Device | Where | Record |
|---|---|---|---|---|
| 2026-09-23 | Hunan Vathin Medical Instrument Co., Ltd. | Single-use Flexible Bronchoscope EOQ | CN | K261637 |
| 2026-09-21 | Ironsides Medical, Inc. | OtoCompanion (Version 1.0) SHL | Cambridge, Massachusetts | K261725 |
| 2026-09-16 | Ambu A/S | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set EOQ | DK | K260309 |
| 2026-09-15 | Karl Storz SE & CO. KG | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) EOB | DE | K254299 |
| 2026-09-02 | Flexicare Medical Limited. | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) EOQ | GB | K254026 |
| 2026-08-26 | Oticon Medical AB | Ponto 5 Mini; Ponto 5 Superpower MAH | SE | K261142 |
| 2026-08-19 | Shokz Health Global Limited | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) LXB | HK | K253431 |
| 2026-08-18 | Grace Medical, Inc. | Tympendi (810) KHJ | Memphis, Tennessee | K260266 |
| 2026-08-13 | Levo Medical Corporation | Levo Gen 2 Tinnitus Therapy System KLW | CA | K260413 |
| 2026-07-31 | Samsung Electronics Co., Ltd. | Hearing Aid Feature SCR | KR | K261187 |
| 2026-07-30 | Spirair, Inc. | SeptAlign (SPLN001) NHB | South San Francisco, Ca | K260620 |
| 2026-07-25 | Auris Health, Inc. | MONARCH Platform (MON-000008) EOQ | Santa Clara, California | K260382 |
| 2026-07-24 | Cook Ireland, Ltd. | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes KTI | IE | K261274 |
| 2026-07-22 | Sounduct | Ossiclear (Ossiclear System) LXB | FR | K254296 |
| 2026-07-13 | Meta Platform Technologies, LLC | Hearing assist SCR | Burlingame, California | K254044 |
| 2026-07-10 | Free Flow Medical, Inc. | LungFlow Airway Catheter EOQ | Fremont, California | K254037 |
| 2026-07-10 | Cochlear Americas | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System PFO | Lone Tree, Colorado | K260902 |
| 2026-06-25 | GN Hearing A/S | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) QUH | DK | K254108 |
| 2026-06-25 | Neuralytix | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) PDQ | Fruita, Colorado | K260992 |
| 2026-06-17 | Stryker Instruments | Hydro Irrigation System EOB | Portage, Michigan | K261544 |
| 2026-06-16 | Fujifilm Corporation | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T EOQ | JP | K253137 |
| 2026-06-15 | Zdeer Technology (Henan) Co., Ltd. | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) LXB | CN | K260452 |
| 2026-06-11 | Shenzhen Magnet Technology Co., Ltd. | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) LXB | CN | K261256 |
| 2026-06-10 | Sivantos GmbH | Tinnitus Therapy KLW | DE | K260614 |
| 2026-05-15 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ Laryngoscopes and Accessories EQN | El Segundo, California | K252624 |
| 2026-05-14 | Optim, LLC | ENTity USB Videoscope System EOB | Sturbridge, Massachusetts | K254133 |
| 2026-05-14 | Elucent Medical | SmartClip Delivery Catheter (ADR-1715) EOQ | Eden Prairie, Minnesota | K260565 |
| 2026-04-26 | Tedan Surgical Innovations | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) PDQ | Sugar Land, Texas | K253580 |
| 2026-04-23 | Olympus Medical Systems Corp. | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) EOQ | JP | K252341 |
| 2026-04-23 | Tusker Medical, Inc. | Tula Tympanostomy Tube Delivery Device ETD | Austin, Texas | K252436 |
| 2026-04-16 | Finemedix Co., Ltd. | ClearTip TBNA Type KTI | KR | K251478 |
| 2026-04-08 | MacroLux Medical Technology Co., Ltd. | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) EOQ | CN | K260420 |
| 2026-04-03 | MED-EL Elektromedizinische Geräte GmbH | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) ETB | AT | K260718 |
| 2026-04-03 | MED-EL Elektromedizinische Geräte GmbH | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 ETA | AT | K260719 |
| 2026-04-03 | MED-EL Elektromedizinische Geräte GmbH | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); ETB | AT | K260720 |
| 2026-03-25 | Zhuhai Wesee Meditech Co., Ltd. | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) EOB | CN | K253184 |
| 2026-03-20 | Olympus Medical Systems Corporation | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D EOB | JP | K252050 |
| 2026-03-17 | Tyto Care , Ltd. | Tyto Insights for Eardrum Bulging Detection SHL | IL | DEN250014 |
| 2026-03-12 | Free Flow Medical, Inc. | LungFlow Basket Catheter KTI | Fremont, California | K254040 |
| 2026-03-04 | Lifevac, LLC | LifeVac QXN | Nesconset, New York | DEN250012 |
| 2026-03-02 | Karl Storz SE & CO. KG | KARL STORZ Mediastinoscopes and Instruments EWY | DE | K260003 |
| 2026-02-27 | Epineuron Technologies, Inc. | Evala Nerve Stimulator (EPNR002) ETN | CA | K253536 |
| 2026-02-19 | Acclarent, Inc. | Acclarent AERA Eustachian Tube Balloon Dilation System PNZ | Irvine, California | K253612 |
| 2026-02-10 | Medtronic Xomed, Inc. | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) ETN | Jacksonville, Florida | K251672 |
| 2026-01-16 | Spirair, Inc. | SeptAlign NHB | South San Francisco, Ca | K251790 |
| 2026-01-09 | Iotamotion, Inc. | iotaSOFT® Insertion System QQH | St. Paul, Minnesota | K252339 |
| 2025-12-19 | Leadoptik, Inc. | LIA-1 Catheter (542-1) KTI | San Jose, California | K251402 |
| 2025-12-12 | Fujifilm Corporation | FUJIFILM Ultrasonic Endoscope EB-710US EOQ | JP | K250863 |
| 2025-12-05 | Karl Storz SE & CO. KG | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) EOQ | DE | K251731 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
All device clearancesFDA warning letters
Cite this page
Permanent URL:
https://mentionfox.com/fda/510k/ear-nose-throatLast updated 2026-10-18
Ear, Nose, Throat device clearances: 49 FDA 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/ear-nose-throat