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).

Sinuscopes · Nasopharyngoscope (Flexible or Rigid) → Ear Nose & Throat

Name: Sinuscopes
Brand: Sinuscopes

7manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

1recall

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 Sinuscopes
Listed by	Pentax of America, Inc., United States
FDA product code	EOB
Device type	Nasopharyngoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4760
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K944656
Record published	2017-04-06
Record revised	2023-11-17 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Sizes	Angle 70 °; outer diameter 2.7 mm

Catalogue Numbers

Catalogue numbers for Sinuscopes
Catalogue number	Size	Status
8852-WA	Angle 70 °	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
K220465	2022-11-16
K183691	2019-06-12
K182846	2019-01-09
K162151	2017-04-20

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-04-06	Class II	Device Design	Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s instrument channel.	215 units	2017-12-21

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.

Sinuscopes