EOB · Class II · 21 CFR 874.4760

FDA Product Code EOB: Nasopharyngoscope (flexible Or Rigid)

Visualization of the nasopharynx is essential in the evaluation of nasal, sinus, and upper airway conditions. FDA product code EOB covers flexible and rigid nasopharyngoscopes and their accessories.

These endoscopes allow ENT specialists to directly inspect the nasal cavity, nasopharynx, and hypopharynx for the diagnosis of nasal polyps, sinusitis, tumors, and voice disorders, and to guide procedures including biopsy and intubation.

EOB devices are Class II medical devices, regulated under 21 CFR 874.4760 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Olympus Medical Systems Corp. and Ambu A/S.

161
Total
161
Cleared
137d
Avg days
1987
Since
Declining activity - 7 submissions in the last 2 years vs 9 in the prior period
Review times increasing: avg 227d recently vs 133d historically

FDA 510(k) Cleared Nasopharyngoscope (flexible Or Rigid) Devices (Product Code EOB)

161 devices
1–24 of 161
Cleared May 14, 2026
ENTity USB Videoscope System
K254133
Optim, LLC
Ear, Nose, Throat · 143d
Cleared Mar 25, 2026
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
K253184
Zhuhai Wesee Meditech Co., Ltd.
Ear, Nose, Throat · 180d
Cleared Mar 20, 2026
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
K252050
Olympus Medical Systems Corporation
Ear, Nose, Throat · 262d
Cleared Aug 11, 2025
Outlook Surgical Versa One System (8900139)
K241731
Resnent, LLC
Ear, Nose, Throat · 420d
Cleared Jun 05, 2025
Portare System (FA-001)
K243639
Grumpy Innovation, Inc.
Ear, Nose, Throat · 192d
Cleared Mar 03, 2025
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K243380
Olympus Medical Systems Corporation
Ear, Nose, Throat · 124d
Cleared Sep 19, 2024
MonoStereo
K234096
Medicaltek Co., Ltd.
Ear, Nose, Throat · 268d
Cleared Apr 26, 2024
Rhinolaryngoscope system
K232435
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Ear, Nose, Throat · 256d
Cleared Aug 03, 2023
ATMOS Scope (507.7000.0)
K232015
Atmos Medizintechnik GmbH & Co. KG
Ear, Nose, Throat · 28d
Cleared Jul 28, 2023
PatCom Distal Chip Endoscope
K222587
H&A Mui Enterprises, Inc.
Ear, Nose, Throat · 336d
Cleared Jun 14, 2023
Single-use Flexible Rhinolaryngoscope
K230536
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat · 107d
Cleared Dec 28, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660
Olympus Medical Systems Corp.
Ear, Nose, Throat · 203d
Cleared Nov 18, 2022
Single-Use Flexible Rhinolaryngoscope
K221581
Hunan Vathin Medical Instrument Co., Ltd.
Ear, Nose, Throat · 170d
Cleared Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
K220465
Pentax of America, Inc.
Ear, Nose, Throat · 272d
Cleared Sep 19, 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638
Olympus Medical Systems Corp.
Ear, Nose, Throat · 105d
Cleared Jul 01, 2022
ENT Nasopharyngoscope and Accessories
K214050
Medimaging Integrated Solution, Inc (Miis)
Ear, Nose, Throat · 186d
Cleared Jun 14, 2022
Zsquare ENT-Flex Endoscope
K220004
Zsquare, Ltd.
Ear, Nose, Throat · 161d
Cleared Jul 23, 2021
Peregrine Endoscopy System
K202727
3nt Medical , Ltd.
Ear, Nose, Throat · 309d
Cleared Jan 13, 2021
ENTity WiFi Video Nasopharyngoscope System
K200609
Optim, LLC
Ear, Nose, Throat · 310d
Cleared Aug 11, 2020
HD Video Rhino Laryngoscope
K200740
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 141d
Cleared Feb 27, 2020
Colibri Endoscopy System
K192305
3nt Medical , Ltd.
Ear, Nose, Throat · 188d
Cleared Jan 27, 2020
CMOS Video Rhino-Laryngoscope SSU
K192090
Karl Storz SE & CO. KG
Ear, Nose, Throat · 175d
Cleared Sep 06, 2019
Rhino-Laryngo Videoscope Olympus ENF-VT3
K183416
Olympus Medical Systems Corp.
Ear, Nose, Throat · 270d
Cleared Sep 06, 2019
Precision S 4K Sinuscope
K191102
Stryker
Ear, Nose, Throat · 134d

About Product Code EOB - Regulatory Context

510(k) Submission Activity

161 total 510(k) submissions under product code EOB since 1987, with 161 receiving FDA clearance (average review time: 137 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - EOB Product Code

Recent submissions under EOB have taken an average of 227 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

EOB devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →