What is FDA product code FDF?

To examine or perform procedures in the colon or rectum 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).

Colonoscope and Accessories, Flexible/Rigid → Gastroenterology & Urology

Name: Colonoscope And Accessories, Flexible/Rigid
Brand: Colonoscope And Accessories, Flexible/Rigid

9manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

8recalls on this code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code FDF
Manufacturer	City	Province	Registered as	Device types
Dalian Create Medical Products Co., Ltd.	Dalian	Liaoning	Contract manufacturer	2
Yangzhou Fartley Medical Instrument Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	24
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
Hangzhou AGS MedTech Co., Ltd.	Hangzhou	Zhejiang	Repacker / relabeller	19
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Guangzhou RED Pine Medical Instrument Co., Ltd.	Guangzhou	Guangdong	Manufacturer	8
Sonoscape Medical Corp.	Shenzhen	Guangdong	Manufacturer	7
Shanghai Seegen Photoelectric Technology Co., Ltd.	Shanghai	Shanghai	Manufacturer	7
Daichuan Medical (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	2

Record

Regulatory record for Colonoscope And Accessories, Flexible/Rigid
Listed by	Pentax of America, Inc., United States
FDA product code	FDF
Device type	Colonoscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K131855
Record published	2018-03-14
Record revised	2018-07-06 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide, Moist Heat or Steam Sterilization, High-level Disinfectant, Sound Waves
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Colonoscope And Accessories, Flexible/Rigid
Catalogue number	Size	Per pack	Status
KUMOF-B190K		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fuse	Endochoice, Inc.	52
Colonoscope And Accessories, Flexible/Rigid	Karl Storz GmbH & Co. KG	51
Fujifilm	Fujifilm Corporation	40
Pentax	Hoya Corporation	37
Video Colonoscope	Pentax of America, Inc.	25
G-EYE Colonoscope	Smart Medical Systems Ltd.	24
Medisono	Medisono, LLC	18
Evis Exera lll Colonovideoscope	Olympus Medical Systems Corp.	16
Endoch	Endoch Inc	14
Evis Exera II Colonovideoscope	Olympus Medical Systems Corp.	12
Colonovideoscope	Olympus Medical Systems Corp.	12
Colonoscope And Accessories, Flexible/Rigid	Hangzhou AGS MedTech Co., Ltd.	10

Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242110	2025-01-03
K181084	2019-01-18
K180285	2018-10-26

Recalls Naming This Product

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

Recalls naming the identifiers of Colonoscope And Accessories, Flexible/Rigid
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Pentax of America, Inc.	510(k) number	2021-07-14	Class II	Device Design	Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families	28849 units Total
Pentax of America, Inc.	510(k) number	2021-07-14	Class II	Device Design	Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families	28849 units Total
Pentax of America, Inc.	510(k) number	2020-01-03	Class II	Mixed-up of materials/components	Distributed in the USA without an approved 510K		2021-01-26
Pentax of America, Inc.	510(k) number	2020-01-03	Class II	Mixed-up of materials/components	Distributed in the USA without an approved 510K	1 unit	2021-01-26
Pentax of America, Inc.	510(k) number	2016-08-15	Class II	Other	Pentax is initiating the product correction of several model numbers of Pentax’s Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU’s that were i	5,090 (US) and 14,209 (OUS)	2018-03-08
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.	12,412 units	2017-12-21

Recalls

2 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
2016-04-06	Class II	Device Design	Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.	10,074 units	2017-07-17
2016-04-06	Class II	Device Design	Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.	12,412 units	2017-07-17

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.

Colonoscope and Accessories, Flexible/Rigid