What is FDA product code EOB?

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).

Single USE Biopsy Valve · Nasopharyngoscope (Flexible or Rigid) → Ear Nose & Throat

Name: Single USE Biopsy Valve
Brand: Single USE Biopsy Valve

7manufacturers in China registered for this device type

2catalogue numbers in this listing

8510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Hunan (2).

Chinese manufacturers registered for FDA product code EOB
Manufacturer	City	Province	Registered as	Device types
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Suzhou Virgil Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Hunan Vathin Medical Instrument Co., Ltd.	Xiangtan	Hunan	Manufacturer	6
Jiana Sterilization Technology (Changsha) Co., Ltd.	Changsha	Hunan	Contract manufacturer	4
Zhuhai Wesee Meditech Co., Ltd.	Zhuhai	Guangdong	Manufacturer	2
Liaoning Jrsd Commercial AND Trading Co., Ltd.	Shenyang	Liaoning	Manufacturer	2

Record

Regulatory record for Single USE Biopsy Valve
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	EOB
Device type	Nasopharyngoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4760
Establishment	Specification developer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2025-10-07 (version 10)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Pack of 70

Catalogue Numbers

Catalogue numbers for Single USE Biopsy Valve
Catalogue number	Size	Per pack	Status
MAJ-210		20	In distribution
MAJ-1218		20	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nasopharyngoscope (Flexible Or Rigid)	Karl Storz GmbH & Co. KG	174
Hopkins	Karl Storz GmbH & Co. KG	99
Jedmed	Jedmed Instrument Company	70
Endo-Scrub®	Medtronic Xomed, Inc.	51
AED	National Advanced Endoscopy Devices, Inc.	49
Sinuscope	Sopro-Comeg GmbH	32
Sharpsite	Medtronic Xomed, Inc.	30
Slide-ON®	Medtronic Xomed, Inc.	29
Slide-ON® Endosheath®	Medtronic Xomed, Inc.	28
Sinuscope	Ecleris SRL	27
Nasopharyngoscope (Flexible Or Rigid)	Pentax of America, Inc.	26
Flex	Medrobotics Corporation	24

Showing 12 of 147. All products under Nasopharyngoscope (Flexible Or Rigid)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252050	2026-03-20
K243380	2025-03-03
K221660	2022-12-28
K221638	2022-09-19
K183416	2019-09-06
K182102	2019-02-06
K181240	2018-10-04
K052452	2005-09-21

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Single USE Biopsy Valve
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Olympus Corporation of the Americas	UDI-DI	2026-01-29	Class II	Under Investigation by firm	Potential for rubber fragment detachment during use.	95,882 boxes (20 per box)
Olympus Corporation of the Americas	UDI-DI	2026-01-29	Class II	Under Investigation by firm	Potential for rubber fragment detachment during use.	1,276 boxes (20 units per box)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Single USE Biopsy Valve