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).

Ear Nose & Throat › SurgicalNasopharyngoscope (Flexible Or Rigid)

Suction-Irrigation-Tube

Name: Suction-irrigation-tube
Brand: Suction-irrigation-tube

10 catalogue numbers from 191 400 105, listed by Sopro-Comeg GmbH, Germany, under Nasopharyngoscope (Flexible Or Rigid). 7 manufacturers in China are registered for this product code.

Registry build 21.09.26

7manufacturers in China registered for this device type

10catalogue numbers in this listing

1510(k) clearance

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 Suction-irrigation-tube
Listed by	Sopro-Comeg GmbH, Germany
FDA product code	EOB
Device type	Nasopharyngoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4760
510(k)	K944656
Record published	2018-03-20
Record revised	2019-03-11 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Suction-irrigation-tube
Catalogue number	Size	Status
191 400 105		In distribution
191 400 110BC		In distribution
191 400 110		In distribution
191 270 105		In distribution
191 270 100BC		In distribution
191 400 100		In distribution
191 400 105BC		In distribution
191 400 100BC		In distribution
191 270 105BC		In distribution
191 270 100		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
K153701	2016-09-09

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.