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).

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

Name: SpyScope DS
Brand: SpyScope DS

8manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

1recall

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 SpyScope DS
Listed by	Boston Scientific Corporation, United States
FDA product code	FBN
Device type	Choledochoscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-24
Record revised	2025-03-18 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for SpyScope DS
Catalogue number	Size	Status
M00546600		In distribution

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
Pentax	Hoya Corporation	5
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

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200483	2020-05-21
K183636	2019-01-22
K181439	2018-08-23
K142922	2015-01-16

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
2017-12-20	Class II	Process design	Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.	5026	2019-12-13

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.

SpyScope DS