EOB · Nasopharyngoscope (Flexible Or Rigid)

Device class

Class II

Regulation 874.4760

Total clearances

2020-01-27 → 2026-06-17

Last 12 months

Unique sponsors

Definition

What is Nasopharyngoscope (Flexible Or Rigid)

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Classification details

Medical specialty

Ear, Nose, Throat

Review panel

Regulation number

874.4760

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Olympus Medical Systems Corporation	4	1	2026-03-20
3nt Medical , Ltd.	2	0	2021-07-23
Hunan Vathin Medical Instrument Co., Ltd.	2	0	2023-06-14
Optim, LLC	2	1	2026-05-14
Shenzhen HugeMed Medical Technical Development Co., Ltd.	1	0	2024-04-26
Karl Storz SE & CO. KG	1	0	2020-01-27
KARL STORZ Endoscopy-America, Inc.	1	0	2020-08-11
Zhuhai Wesee Meditech Co., Ltd.	1	1	2026-03-25
Medicaltek Co., Ltd.	1	0	2024-09-19
Zsquare, Ltd.	1	0	2022-06-14
Grumpy Innovation, Inc.	1	0	2025-06-05
Resnent, LLC	1	0	2025-08-11
Medimaging Integrated Solution, Inc (Miis)	1	0	2022-07-01
Stryker Instruments	1	1	2026-06-17
Pentax of America, Inc.	1	0	2022-11-16
H&A Mui Enterprises, Inc.	1	0	2023-07-28
Atmos Medizintechnik GmbH & Co. KG	1	0	2023-08-03

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
31231	CPT	—	High	Nasal endoscopy (flexible or rigid); nasopharyngoscopy standard procedure code
31575	CPT	—	Medium	Laryngoscopy, flexible, with stroboscopy; overlapping flexible endoscopy procedures

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-17	K261544	Stryker Instruments	Hydro Irrigation System
2026-05-14	K254133	Optim, LLC	ENTity USB Videoscope System
2026-03-25	K253184	Zhuhai Wesee Meditech Co., Ltd.	Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
2026-03-20	K252050	Olympus Medical Systems Corporation	Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
2025-08-11	K241731	Resnent, LLC	Outlook Surgical Versa One System (8900139)
2025-06-05	K243639	Grumpy Innovation, Inc.	Portare System (FA-001)
2025-03-03	K243380	Olympus Medical Systems Corporation	VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
2024-09-19	K234096	Medicaltek Co., Ltd.	MonoStereo
2024-04-26	K232435	Shenzhen HugeMed Medical Technical Development Co., Ltd.	Rhinolaryngoscope system
2023-08-03	K232015	Atmos Medizintechnik GmbH & Co. KG	ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
2023-07-28	K222587	H&A Mui Enterprises, Inc.	PatCom Distal Chip Endoscope
2023-06-14	K230536	Hunan Vathin Medical Instrument Co., Ltd.	Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
2022-12-28	K221660	Olympus Medical Systems Corp.	RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
2022-11-18	K221581	Hunan Vathin Medical Instrument Co., Ltd.	Single-Use Flexible Rhinolaryngoscope
2022-11-16	K220465	Pentax of America, Inc.	PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
2022-09-19	K221638	Olympus Medical Systems Corp.	Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
2022-07-01	K214050	Medimaging Integrated Solution, Inc (Miis)	ENT Nasopharyngoscope and Accessories
2022-06-14	K220004	Zsquare, Ltd.	Zsquare ENT-Flex Endoscope
2021-07-23	K202727	3nt Medical , Ltd.	Peregrine Endoscopy System
2021-01-13	K200609	Optim, LLC	ENTity WiFi Video Nasopharyngoscope System
2020-08-11	K200740	KARL STORZ Endoscopy-America, Inc.	HD Video Rhino Laryngoscope
2020-02-27	K192305	3nt Medical , Ltd.	Colibri Endoscopy System
2020-01-27	K192090	Karl Storz SE & CO. KG	CMOS Video Rhino-Laryngoscope SSU