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).

Flex-X · Nasopharyngoscope (Flexible or Rigid) → Ear Nose & Throat

Name: Flex-X
Brand: Flex-X

7manufacturers in China registered for this device type

1catalogue number

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 Flex-X
Listed by	Karl Storz GmbH & Co. KG
FDA product code	EOB
Device type	Nasopharyngoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4760
510(k)	K171402
Record published	2019-02-23
Record revised	2023-11-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Peracetic Acid, Hydrogen Peroxide, High-level Disinfectant, Ethylene Oxide
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Flex-X
Catalogue number	Size	Status
11161V		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)

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Flex-X
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Karl Storz Endoscopy-America, Inc.	510(k) number	2022-04-01	Class II	Under Investigation by firm	Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.	All Serial Numbers manufactured/distributed since January 20

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.

Flex-X