Part 874 Subpart E—Surgical Devices
FDA submissions for Part 874 Subpart E—Surgical Devices in the Ear, Nose, Throat (EN) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 874.4100–874.4800
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| EMX | Balloon, Epistaxis | 874.4100 | 1 | 47 |
| EQJ | Bur, Ear, Nose And Throat | 874.4140 | 1 | 18 |
| NLY | Microdebrider, Ent, High Speed, Single Use, Reprocessed | 874.4140 | 1 | 1 |
| NLZ | Bur, Ent, Diamond Coated, Single Use, Reprocessed | 874.4140 | 1 | 0 |
| ENW | Catheter, Nasopharyngeal | 874.4175 | 1 | 2 |
| KBI | Bougie, Eustachian | 874.4175 | 1 | 1 |
| KBY | Set, Filliform, Eustachian | 874.4175 | 1 | 0 |
| PNZ | Eustachian Tube Balloon Dilation Device | 874.4180 | 2 | 9 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 874.4250 | 2 | 91 |
| EQH | Source, Carrier, Fiberoptic Light | 874.4350 | 1 | 49 |
| MQW | Transilluminator, Fiber Optic | 874.4350 | 1 | 1 |
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | 874.4420 | 1 | 2 |
| JYE | Chisel, Middle-Ear | 874.4420 | 1 | 1 |
| JYF | Clamp, Ossicle Holding | 874.4420 | 1 | 0 |
| JYG | Curette, Ear | 874.4420 | 1 | 7 |
| JYH | Excavator, Ear | 874.4420 | 1 | 0 |
| JYI | Gauge, Mastoid | 874.4420 | 1 | 0 |
| JYJ | Gauge, Measuring | 874.4420 | 1 | 5 |
| JYL | Hook, Microsurgical Ear | 874.4420 | 1 | 5 |
| JYM | Inserter, Myringotomy Tube | 874.4420 | 1 | 4 |
| JYN | Inserter, Sacculotomy Tack | 874.4420 | 1 | 0 |
| JYO | Knife, Ear | 874.4420 | 1 | 7 |
| JYP | Knife, Myringotomy | 874.4420 | 1 | 1 |
| JYQ | Loop, Wire | 874.4420 | 1 | 2 |
| JYR | Nipper, Malleus | 874.4420 | 1 | 2 |
| JYS | Perforator, Ear-Lobe | 874.4420 | 1 | 3 |
| JYT | Pick, Microsurgical Ear | 874.4420 | 1 | 2 |
| JYW | Press, Vein | 874.4420 | 1 | 1 |
| JYX | Punch, Attic | 874.4420 | 1 | 0 |
| JYY | Rasp, Ear | 874.4420 | 1 | 1 |
| JYZ | Rod, Measuring Ear | 874.4420 | 1 | 1 |
| JZA | Rongeur, Mastoid | 874.4420 | 1 | 1 |
| JZB | Scissors, Ear | 874.4420 | 1 | 4 |
| JZC | Searcher, Mastoid | 874.4420 | 1 | 0 |
| JZD | Snare, Ear | 874.4420 | 1 | 2 |
| JZE | Spoon, Ear | 874.4420 | 1 | 1 |
| JZF | Tube, Ear Suction | 874.4420 | 1 | 5 |
| JZY | Knife, Laryngeal | 874.4420 | 1 | 0 |
| JZZ | Saw, Laryngeal | 874.4420 | 1 | 0 |
| KAA | Set, Laryngeal Injection | 874.4420 | 1 | 0 |
| KAB | Trocar, Laryngeal | 874.4420 | 1 | 1 |
| KAC | Tube, Laryngectomy | 874.4420 | 1 | 4 |
| KAD | Elevator, Ent | 874.4420 | 1 | 5 |
| KAE | Forceps, Ent | 874.4420 | 1 | 14 |
| KAH | Microrule, Ent | 874.4420 | 1 | 0 |
| KAI | Mirror, Ent | 874.4420 | 1 | 9 |
| KAJ | Mobilizer, Ent | 874.4420 | 1 | 0 |
| KAK | Probe, Ent | 874.4420 | 1 | 1 |
| KAL | Retractor, Ent | 874.4420 | 1 | 5 |
| KAO | Curette, Ethmoid | 874.4420 | 1 | 0 |
| KAP | Curette, Nasal | 874.4420 | 1 | 1 |
| KAQ | Gouge, Nasal, Ent | 874.4420 | 1 | 0 |
| KAR | Irrigator, Sinus | 874.4420 | 1 | 3 |
| KAS | Knife, Nasal | 874.4420 | 1 | 1 |
| KAT | Perforator, Antrum | 874.4420 | 1 | 0 |
| KAW | Punch, Antrum | 874.4420 | 1 | 0 |
| KAX | Punch, Ethmoid | 874.4420 | 1 | 0 |
| KAY | Punch, Nasal | 874.4420 | 1 | 0 |
| KAZ | Rasp, Frontal-Sinus | 874.4420 | 1 | 0 |
| KBA | Rasp, Nasal | 874.4420 | 1 | 0 |
| KBB | Rongeur, Nasal | 874.4420 | 1 | 0 |
| KBC | Saw, Nasal | 874.4420 | 1 | 4 |
| KBD | Scissors, Nasal | 874.4420 | 1 | 3 |
| KBE | Snare, Nasal | 874.4420 | 1 | 0 |
| KBF | Trephine, Sinus | 874.4420 | 1 | 1 |
| KBG | Trocar, Sinus | 874.4420 | 1 | 3 |
| KBH | Adenotome | 874.4420 | 1 | 1 |
| KBJ | Curette, Adenoid | 874.4420 | 1 | 1 |
| KBK | Curette, Salpingeal | 874.4420 | 1 | 0 |
| KBL | Depressor, Metal Tongue, Surgical | 874.4420 | 1 | 1 |
| KBM | Dissector, Tonsil | 874.4420 | 1 | 1 |
| KBN | Gag, Mouth | 874.4420 | 1 | 3 |
| KBO | Guillotine, Tonsil | 874.4420 | 1 | 1 |
| KBP | Hook, Tonsil Suturing | 874.4420 | 1 | 0 |
| KBQ | Knife, Tonsil | 874.4420 | 1 | 1 |
| KBR | Needle, Tonsil Suturing | 874.4420 | 1 | 0 |
| KBS | Punch, Adenoid | 874.4420 | 1 | 0 |
| KBT | Punch, Tonsil | 874.4420 | 1 | 0 |
| KBW | Screw, Oral | 874.4420 | 1 | 1 |
| KBX | Screw, Tonsil | 874.4420 | 1 | 0 |
| KBZ | Snare, Tonsil | 874.4420 | 1 | 1 |
| KCA | Tonsillectome | 874.4420 | 1 | 1 |
| KCB | Tube, Tonsil Suction | 874.4420 | 1 | 1 |
| KCC | Bistoury, Tracheal | 874.4420 | 1 | 0 |
| KCD | Bougie, Esophageal, Ent | 874.4420 | 1 | 3 |
| KCF | Dilator, Esophageal, Ent | 874.4420 | 1 | 3 |
| KCG | Dilator, Tracheal | 874.4420 | 1 | 1 |
| KCH | Hook, Tracheal | 874.4420 | 1 | 0 |
| KCI | Trocar, Tracheal | 874.4420 | 1 | 0 |
| KTE | Trocar, Ent | 874.4420 | 1 | 1 |
| KTF | Punch, Ent | 874.4420 | 1 | 0 |
| KTG | Knife, Ent | 874.4420 | 1 | 5 |
| LJW | Tracheotome | 874.4420 | 1 | 2 |
| LRC | Instrument, Ent Manual Surgical | 874.4420 | 1 | 65 |
| MMO | Tray, Surgical, Ent | 874.4420 | 1 | 1 |
| NLB | Trocar, Tracheal, Laryngeal, Sinus, Reprocessed | 874.4420 | 1 | 0 |
| OGR | Ear, Nose, And Throat Surgical Tray | 874.4420 | 1 | 0 |
| OGU | Pierced Ear/Entry Cleaning Tray | 874.4420 | 1 | 0 |
| QGK | Balloon, Nasal Airway | 874.4420 | 1 | 1 |
| SBS | Laryngeal Injection Set With Led Light | 874.4420 | 1 | 1 |
| QQH | Powered Insertion System For A Cochlear Implant Electrode Array | 874.4450 | 2 | 2 |
| QXG | Cooperative Powered Surgical Assist Device For Ent Surgery | 874.4460 | 2 | 1 |
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | 874.4490 | 2 | 2 |
| LXR | Laser, Microsurgical Argon, For Use In Otology | 874.4490 | 2 | 0 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 874.4500 | 2 | 24 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 874.4500 | 2 | 19 |
| BST | Curette, Biopsy, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 0 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 6 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 6 |
| ENZ | Telescope, Laryngeal-Bronchial | 874.4680 | 2 | 3 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 874.4680 | 2 | 236 |
| JEI | Claw, Foreign Body, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 0 |
| JEJ | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) | 874.4680 | 2 | 2 |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | 874.4680 | 2 | 3 |
| JEL | Curette, Biopsy, Bronchoscope (Rigid) | 874.4680 | 2 | 1 |
| KTI | Bronchoscope Accessory | 874.4680 | 2 | 33 |
| KTR | Tube, Aspirating, Bronchoscope, Rigid | 874.4680 | 2 | 4 |
| NLE | Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed | 874.4680 | 2 | 0 |
| QNW | Reprocessed Bronchoscope | 874.4680 | 2 | 2 |
| EOX | Esophagoscope (Flexible Or Rigid) | 874.4710 | 2 | 30 |
| EWY | Mediastinoscope, Surgical | 874.4720 | 2 | 11 |
| EQL | Laryngostroboscope | 874.4750 | 1 | 8 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 874.4760 | 2 | 160 |
| EQN | Laryngoscope, Nasopharyngoscope | 874.4760 | 2 | 21 |
| ERA | Otoscope | 874.4770 | 1 | 56 |
| SHL | Ear, Nose, And Throat Image Analyzer | 874.4775 | 2 | 1 |
| LYA | Splint, Intranasal Septal | 874.4780 | 1 | 46 |
| QJL | Splint, Intranasal Septal, Cber Led | 874.4780 | 1 | 1 |
| MXP | Bone Particle Collector | 874.4800 | 1 | 0 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | Apr 16, 2026 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | Apr 8, 2026 |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | Mar 25, 2026 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | Mar 20, 2026 |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | Mar 17, 2026 |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | Mar 12, 2026 |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | Mar 2, 2026 |
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | Feb 19, 2026 |
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | Jan 9, 2026 |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | Dec 19, 2025 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | Dec 12, 2025 |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | Dec 5, 2025 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | Oct 8, 2025 |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | Sep 26, 2025 |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Sep 23, 2025 |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | Sep 23, 2025 |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Sep 5, 2025 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | Aug 27, 2025 |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. | Aug 11, 2025 |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | Aug 11, 2025 |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation | Jul 29, 2025 |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | Jul 25, 2025 |
| K243655 | TurbAlign | Spirair, Inc. | Jul 11, 2025 |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W&H Dentalwerk Buermoos GmbH | Jul 3, 2025 |
| K250862 | EVIS 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) | Olympus Medical Systems Corp. | Jun 23, 2025 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | Jun 13, 2025 |
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | Jun 12, 2025 |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | Jun 5, 2025 |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | Jun 4, 2025 |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corporation | May 30, 2025 |
| K243497 | Portable 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-28US | Shanghai AnQing Medical Instrument Co., Ltd. | May 29, 2025 |
| K242793 | Insighters 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. | Shenzhen Insighters Medical Technology Co., Ltd. | May 28, 2025 |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC | Apr 30, 2025 |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | Mar 31, 2025 |
| K250210 | Broncho 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)) | Scivita Medical Technology Co., Ltd. | Mar 19, 2025 |
| K242010 | Bronchoscope 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) | Shenzhen Sanping Image Technology Co., Ltd. | Mar 14, 2025 |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Mar 4, 2025 |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | Mar 3, 2025 |
| K242324 | DUTAU-NOVATECH® | Novatech SA | Feb 6, 2025 |
| K243219 | MONARCH Platform (MON-000008) | Auris Health, Inc. | Jan 23, 2025 |
| K242416 | Single-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-50mL | Hunan Vathin Medical Instrument Co., Ltd. | Jan 16, 2025 |
| K241612 | Video 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) | Hunan Vathin Medical Instrument Co., Ltd. | Oct 29, 2024 |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Scivita Medical Technology Co., Ltd. | Oct 23, 2024 |
| K242070 | Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. | Sep 24, 2024 |
| K234096 | MonoStereo | Medicaltek Co., Ltd. | Sep 19, 2024 |
| K232177 | Lightin System, Lightin, Lightin Generator | Solmedix Co., Ltd. | Jul 10, 2024 |
| K232601 | BroncTru Transbronchial Access Tool | Broncus Medical, Inc. | May 31, 2024 |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | Medimaging Integrated Solution, Inc (Miis) | May 1, 2024 |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Apr 26, 2024 |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. | Apr 26, 2024 |
| 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. | Apr 5, 2024 |
| K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. | Apr 3, 2024 |
| K233958 | hekaDrill | Zethon, Ltd. | Mar 14, 2024 |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. | Feb 15, 2024 |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | Feb 7, 2024 |
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | Jan 19, 2024 |
| 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. | Jan 18, 2024 |
| 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. | Jan 12, 2024 |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Ambu A/S | Jan 4, 2024 |
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Dec 18, 2023 |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | Dec 13, 2023 |
| K231473 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | Nov 28, 2023 |
| K231818 | METIC- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. | Nov 15, 2023 |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | Nov 14, 2023 |
| K230778 | EndoCore | Praxis Medical, LLC | Sep 25, 2023 |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | Sep 20, 2023 |
| K230428 | Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Ambu A/S | Aug 10, 2023 |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | Atmos Medizintechnik GmbH & Co. KG | Aug 3, 2023 |
| K223542 | TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH | Aug 3, 2023 |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | Jul 28, 2023 |
| DEN220047 | Galen ES Cooperative Surgical Assistant Platform, Galen ES | Galen Robotics | Jul 19, 2023 |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corporation | Jun 15, 2023 |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | Jun 14, 2023 |
| 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 | Jun 1, 2023 |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System | Fiagon GmbH | May 26, 2023 |
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | May 25, 2023 |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | May 15, 2023 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | May 11, 2023 |
| K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | May 3, 2023 |
| K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Apr 11, 2023 |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | Mar 22, 2023 |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | Boston Scientific Corporation | Mar 2, 2023 |
| K223144 | Galaxy System | Noah Medical Corp. | Mar 1, 2023 |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | Mar 1, 2023 |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | Feb 24, 2023 |
| 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 | Jan 12, 2023 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | Dec 28, 2022 |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | Pentax of America, Inc. | Dec 21, 2022 |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | Dec 2, 2022 |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | Nov 18, 2022 |
| 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. | Nov 16, 2022 |
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | Nov 14, 2022 |
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | Nov 10, 2022 |
| K221184 | ORiGO System | Bien-Air Surgery SA | Nov 2, 2022 |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | Oct 26, 2022 |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | Olympus Medical Systems Corp. | Sep 26, 2022 |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | Olympus Medical Systems Corp. | Sep 19, 2022 |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | Aug 25, 2022 |
| K221302 | Recon Steerable Sheath | Serpex Medical, Inc. | Aug 15, 2022 |
| K222014 | EXALT Model B Single-Use Bronchoscope | Boston Scientific Corporation | Jul 28, 2022 |
