What is FDA product code FBN?

to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).

Pentax · Choledochoscope and Accessories, Flexible/Rigid → Gastroenterology & Urology

Name: Pentax
Brand: Pentax

8manufacturers in China registered for this device type

5catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Shanghai (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FBN
Manufacturer	City	Province	Registered as	Device types
Ningbo Wise Optomech Technology Corporation	Ningbo	Zhejiang	Contract manufacturer	4
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Zhuhai Pusen Medical Technology Co., Ltd.	Zhuhai	Guangdong	Manufacturer	7
Shanghai Seegen Photoelectric Technology Co., Ltd.	Shanghai	Shanghai	Manufacturer	7
Eternal (Shanghai) Medical Technology Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	7
Shenzhen Besdata Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6
Shanghai AnQing Medical Instrument Co., Ltd.	Shanghai	Shanghai	Manufacturer	5

Record

Regulatory record for Pentax
Listed by	Hoya Corporation, Bulgaria
FDA product code	FBN
Device type	Choledochoscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Manufacturer, Exporter
510(k)	K953286
Record published	2023-07-31
Record revised	2025-04-07 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	High-level Disinfectant, Ethylene Oxide, Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number
Distribution end date	2023-07-31
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Pentax
Catalogue number	Size	Status
OF-B103		In distribution
OF-B84		In distribution
OF-B82		Withdrawn
FCP-9P		Withdrawn
KA1811S		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Single-use Video Scope	Micro-Tech (Nanjing) Co., Ltd.	24
Choledochoscope And Accessories, Flexible/Rigid	Richard Wolf Gmbh	8
Single-Use Choledochoscope	Shenzhen Hugemed Medical Technical Development Co., Ltd.	6
Flexible Video-Choledo-Cysto-Ureteroscope	Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory)	5
Riwo	Richard Wolf Gmbh	4
Flexible Video-Choledochoscope	Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory)	4
WiScope®	OTU Medical Inc	4
Choledochoscope And Accessories, Flexible/Rigid	Karl Storz GmbH & Co. KG	4
OES Uretero-Reno Fiberscope	Olympus Medical Systems Corp.	3
Gyrus Acmi	Gyrus Acmi, Inc.	3
Fiber Pancreatoscope	Pentax of America, Inc.	2
OES Transduodenal Choledochofiberscope	Olympus Medical Systems Corp.	2

Showing 12 of 34. All products under Choledochoscope And Accessories, Flexible/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 Pentax
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.	50 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.

Pentax