EOB · Nasopharyngoscope (Flexible Or Rigid)
Ear, Nose, Throat · 21 CFR 874.4760 · Class 2
Overview
| Product Code | EOB |
|---|---|
| Device Name | Nasopharyngoscope (Flexible Or Rigid) |
| Regulation | 21 CFR 874.4760 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 160)
Showing 20 most recent of 160 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | Mar 25, 2026 | SESE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | Mar 20, 2026 | SESE |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | Aug 11, 2025 | SESE |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | Jun 5, 2025 | SESE |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | Mar 3, 2025 | SESE |
| K234096 | MonoStereo | Medicaltek Co., Ltd. | Sep 19, 2024 | SESE |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Apr 26, 2024 | SESE |
| 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 | SESE |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | Jul 28, 2023 | SESE |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | Jun 14, 2023 | SESE |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | Dec 28, 2022 | SESE |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | Nov 18, 2022 | SESE |
| 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 | SESE |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | Olympus Medical Systems Corp. | Sep 19, 2022 | SESE |
| K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | Jul 1, 2022 | SESE |
| K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | Jun 14, 2022 | SESE |
| K202727 | Peregrine Endoscopy System | 3nt Medical , Ltd. | Jul 23, 2021 | SESE |
| K200609 | ENTity WiFi Video Nasopharyngoscope System | Optim, LLC | Jan 13, 2021 | SESE |
| K200740 | HD Video Rhino Laryngoscope | KARL STORZ Endoscopy-America, Inc. | Aug 11, 2020 | SESE |
| K192305 | Colibri Endoscopy System | 3nt Medical , Ltd. | Feb 27, 2020 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 27 clearances
- Vision-Sciences, Inc. — 15 clearances
- Olympus Medical Systems Corp. — 5 clearances
- Acclarent, Inc. — 4 clearances
- Pentax of America, Inc. — 4 clearances
