Panels › Ear, Nose, Throat › Product code EOB · Class 2
Nasopharyngoscope (Flexible Or Rigid)
Regulation 874.4760
5510(k)s in 12 months (163 all time)
1recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in EOB
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 28 | 0 |
| Vision-Sciences, Inc. | 15 | 2 |
| Olympus Medical Systems Corp. | 8 | 0 |
| Acclarent, Inc. | 4 | 0 |
| Pentax of America, Inc. | 4 | 0 |
| 3nt Medical , Ltd. | 3 | 0 |
| Ambu A/S | 3 | 0 |
| Karl Storz Endoscopy | 1 | 2 |
| Olympus America, Inc. | 3 | 0 |
| Olympus Corporation of the Americas | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2026 | K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° Karl Storz SE & CO. KG, DE | EOB |
| Jun 17, 2026 | K261544 | Hydro Irrigation System Stryker Instruments | EOB |
| May 14, 2026 | K254133 | ENTity USB Videoscope System Optim, LLC | EOB |
| Mar 25, 2026 | K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) Zhuhai Wesee Meditech Co., Ltd., CN | EOB |
| Mar 20, 2026 | K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D Olympus Medical Systems Corporation, JP | EOB |
| Aug 11, 2025 | K241731 | Outlook Surgical Versa One System (8900139) Resnent, LLC | EOB |
| Jun 5, 2025 | K243639 | Portare System (FA-001) Grumpy Innovation, Inc. | EOB |
| Mar 3, 2025 | K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) Olympus Medical Systems Corporation, JP | EOB |
| Sep 19, 2024 | K234096 | MonoStereo Medicaltek Co., Ltd., TW | EOB |
| Apr 26, 2024 | K232435 | Rhinolaryngoscope system Shenzhen HugeMed Medical Technical Development Co., Ltd., CN | EOB |
| Aug 3, 2023 | K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) Atmos Medizintechnik GmbH & Co. KG, DE | EOB |
| Jul 28, 2023 | K222587 | PatCom Distal Chip Endoscope H&A Mui Enterprises, Inc., CA | EOB |
| Jun 14, 2023 | K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor Hunan Vathin Medical Instrument Co., Ltd., CN | EOB |
| Dec 28, 2022 | K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP Olympus Medical Systems Corp., JP | EOB |
| Nov 18, 2022 | K221581 | Single-Use Flexible Rhinolaryngoscope Hunan Vathin Medical Instrument Co., Ltd., CN | EOB |
| Nov 16, 2022 | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK- Pentax of America, Inc. | EOB |
| Sep 19, 2022 | K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 Olympus Medical Systems Corp., JP | EOB |
| Jul 1, 2022 | K214050 | ENT Nasopharyngoscope and Accessories Medimaging Integrated Solution, Inc (Miis), TW | EOB |
| Jun 14, 2022 | K220004 | Zsquare ENT-Flex Endoscope Zsquare, Ltd., IL | EOB |
| Jul 23, 2021 | K202727 | Peregrine Endoscopy System 3nt Medical , Ltd., IL | EOB |
| Jan 13, 2021 | K200609 | ENTity WiFi Video Nasopharyngoscope System Optim, LLC | EOB |
| Aug 11, 2020 | K200740 | HD Video Rhino Laryngoscope KARL STORZ Endoscopy-America, Inc. | EOB |
| Feb 27, 2020 | K192305 | Colibri Endoscopy System 3nt Medical , Ltd., IL | EOB |
| Jan 27, 2020 | K192090 | CMOS Video Rhino-Laryngoscope SSU Karl Storz SE & CO. KG, DE | EOB |
| Sep 6, 2019 | K191102 | Precision S 4K Sinuscope Stryker | EOB |
| Sep 6, 2019 | K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 Olympus Medical Systems Corp., JP | EOB |
| Jul 12, 2019 | K190972 | Ambu aScope 4 RhinoLaryngo Intervention Ambu A/S, DK | EOB |
| Jun 12, 2019 | K183691 | PENTAX Medical ENT Video Imaging System Pentax of America, Inc. | EOB |
| May 22, 2019 | K191080 | Ambu aScope 4 RhinoLaryngo Slim Ambu A/S, DK | EOB |
| Mar 22, 2019 | K182186 | CMOS Video-Rhino-Laryngoscope System KARL STORZ Endoscopy-America, Inc. | EOB |
| Feb 6, 2019 | K182102 | RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 Olympus Medical Systems Corp., JP | EOB |
| Jan 9, 2019 | K182846 | PENTAX Medical EPK-3000 Video Imaging System Pentax of America, Inc. | EOB |
| Nov 30, 2018 | K181286 | Ambu aScope RLS Slim Ambu A/S, DK | EOB |
| Oct 4, 2018 | K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 Olympus Medical Systems Corp., JP | EOB |
| Jul 18, 2018 | K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution Pentax Medical | EOB |
| Apr 20, 2018 | K173855 | Sharpsite AC Rigid Endsocope Medtronic Xomed, Inc. | EOB |
| Apr 5, 2018 | K172156 | PENTAX Medical EPK-3000 Video Imaging System Pentax Medical | EOB |
| Feb 2, 2018 | K171402 | KARL STORZ Slim Nasopharyngolaryngoscope KARL STORZ Endoscopy-America, Inc. | EOB |
| Oct 19, 2017 | K170453 | Medrobotics Flex Robotic System Medrobotics Corporation | EOB |
| Aug 25, 2017 | K161298 | ShenDa Sinuscope Shenyang Shenda Endoscope Co., Ltd., CN | EOB |
| Aug 1, 2017 | K170285 | AED Sinuscope National Advanced Endoscopy Devices, Inc. | EOB |
| Apr 20, 2017 | K162151 | PENTAX Medical ENT Video Imaging System Pentax of America, Inc. | EOB |
| Mar 2, 2017 | K162410 | TIPCAM 1S 3D System Karl Storz Endoscopy America, Inc. | EOB |
| Feb 24, 2017 | K162916 | 3NT endoscopy system 3nt Medical , Ltd., IL | EOB |
| Sep 9, 2016 | K153701 | ULYSS Multi View Sinuscope Sopro-Comeg GmbH, DE | EOB |
| Apr 5, 2016 | K153009 | ULTRA Telescopes Olympus Winter & Ibe GmbH, DE | EOB |
| Jan 15, 2016 | K152531 | InstaClear Lens Cleaner Gyrus Acmi, Inc. | EOB |
| Jul 17, 2015 | K150776 | Medrobotics Flex System Medrobotics Corporation | EOB |
| Mar 4, 2015 | K143673 | CMOS Video Nasopharyngoscope System Schoelly Fiberoptic GmbH, DE | EOB |
| Jan 27, 2015 | K142249 | SCHOELLY SINUSCOPE Schoelly Fiberoptic GmbH, DE | EOB |
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