What is FDA product code EOQ?

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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).

Fiber Bronchoscope · Bronchoscope (Flexible or Rigid) → Ear Nose & Throat

Name: Fiber Bronchoscope
Brand: Fiber Bronchoscope

21manufacturers in China registered for this device type

7catalogue numbers in this listing

9510(k) clearances naming this product code

8recalls on this code

Who Else Makes It

Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EOQ
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	9
Ningbo Wise Optomech Technology Corporation	Ningbo	Zhejiang	Contract manufacturer	4
Hangzhou Broncus Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	1
Tianjin Puli Ark Medical Technology Co., Ltd.	Dongli District	Tianjin	Contract manufacturer	1
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Huanyi Sterilization Technology Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	25
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Suzhou Prosteri Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Suzhou Virgil Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Anrei Medical (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	12

Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)

Record

Regulatory record for Fiber Bronchoscope
Listed by	Pentax of America, Inc., United States
FDA product code	EOQ
Device type	Bronchoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4680
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K951199
Record published	2017-04-06
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide, High-level Disinfectant
Prescription	Prescription only
Label carries	lot or batch number, serial number
Distribution end date	2017-04-06

Catalogue Numbers

Catalogue numbers for Fiber Bronchoscope
Catalogue number	Size	Status
FB-18V		In distribution
FB-15V		In distribution
FB-8V		In distribution
FB-15RBS		In distribution
FB-18RBS		In distribution
FB-15P		Withdrawn
FB-18P		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bronchoscope (Flexible Or Rigid)	Karl Storz GmbH & Co. KG	248
Pentax	Hoya Corporation	39
Biopsy Forceps	Olympus Medical Systems Corp.	31
Single-Use flexible Video Bronchoscope	Hunan Vathin Medical Instrument Co., Ltd.	27
Pilling	Teleflex Medical LLC	24
Silicone cap	Efer Endoscopy	22
Bronchoscope (Flexible Or Rigid)	Intuitive Surgical, Inc.	20
Endoso	Hunan Endoso Life Technology Co., Ltd.	20
Exalt ™	Boston Scientific Corporation	17
Grasping Forceps	Olympus Medical Systems Corp.	16
LungVision Tool	Body Vision Medical Ltd	16
Fujifilm	Fujifilm Corporation	15

Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232860	2024-01-18
K231970	2024-01-12
K213235	2022-12-21
K210928	2021-10-21
K200678	2020-07-30
K183516	2019-09-06
K183654	2019-05-23
K173554	2018-01-19
K143727	2015-10-29

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Fiber Bronchoscope
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Pentax of America, Inc.	510(k) number	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.	4,195 units	2017-12-21
Pentax of America, Inc.	510(k) number	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.	115 units	2017-12-21

Recalls

5 of these are 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
2016-05-31	Class II	Process control	The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cl	113 units	2019-08-19
2016-05-31	Class II	Packaging process control	Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.	1719 units	2017-12-21
2011-09-30	Not classified	Employee error	The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.	18 units	2012-11-27
2011-01-11	Class II	Device Design	This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.	1,349 – (Total – US) and 352 (Total – OUS)	2018-03-13
2011-01-11	Class II	Device Design	This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.	1,349 – (Total – US) and 352 (Total – OUS)	2018-03-13
2011-01-11	Class II	Device Design	This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.	1,349 – (Total – US) and 352 (Total – OUS)	2018-03-13

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.

Fiber Bronchoscope