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).

Gastroenterology & Urology › DiagnosticColonoscope And Accessories, Flexible/Rigid

Evis Exera III Xenon Light Source

Name: Evis Exera III Xenon Light Source
Brand: Evis Exera III Xenon Light Source

CLV-190 Evis Exera III Light Source

Registry build 21.09.26

9manufacturers in China registered for this device type

2catalogue numbers in this listing

7510(k) clearances naming this product 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 Evis Exera III Xenon Light Source
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	FDF
Device type	Colonoscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K121959
Record published	2016-09-21
Record revised	2024-04-22 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Evis Exera III Xenon Light Source
Catalogue number	Size	Status
OLYMPUS CLV-190		In distribution
OLYMPUS CLV-190		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
K250432	2025-05-15
K192793	2020-07-17
K131780	2013-08-29
K111756	2012-03-20
K112680	2012-02-16
K103312	2011-05-12
K101053	2010-07-14

Recalls Naming This Product

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

Recalls naming the identifiers of Evis Exera III Xenon Light Source
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Olympus Corporation of the Americas	510(k) number	2025-09-11	Class I	Device Design	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.	4,297 units US; 4,290 units OUS
Olympus Corporation of the Americas	510(k) number	2025-09-11	Class I	Device Design	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.	0 units US; 2,092 units OUS
Olympus Corporation of the Americas	510(k) number	2025-09-11	Class I	Device Design	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.	5,221 units US; 4,321 units OUS
Olympus Corporation of the Americas	510(k) number	2025-09-11	Class I	Device Design	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.	1 unit US; 2,306 units OUS
Olympus Corporation of the Americas	510(k) number	2025-09-11	Class I	Device Design	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.	916 units US; 1,402 units OUS
Olympus Corporation of the Americas	510(k) number	2024-01-11	Class II	Nonconforming Material/Component	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.	47
Aizu Olympus Co., Ltd.	510(k) number	2023-10-16	Class II	Process control	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to e	24 incorrectly repaired units
Aizu Olympus Co., Ltd.	510(k) number	2023-10-16	Class II	Process control	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to e	24 incorrectly repaired units
Aizu Olympus Co., Ltd.	510(k) number	2023-10-16	Class II	Process control	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to e	24 incorrectly repaired units
Aizu Olympus Co., Ltd.	510(k) number	2023-10-16	Class II	Process control	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to e	24 incorrectly repaired units
Aizu Olympus Co., Ltd.	510(k) number	2023-10-16	Class II	Process control	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to e	24 incorrectly repaired units
Olympus Corporation of the Americas	510(k) number	2023-10-12	Class I	Under Investigation by firm	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.	32211 devices
Aizu Olympus Co., Ltd.	510(k) number	2023-09-25	Class II	Under Investigation by firm	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead t	1123 units
Aizu Olympus Co., Ltd.	510(k) number	2023-09-25	Class II	Under Investigation by firm	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead t	3101 units
Olympus Corporation of the Americas	510(k) number	2023-09-14	Class II	Nonconforming Material/Component	Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.	45 units
Olympus Corporation of the Americas	510(k) number	2023-07-27	Class II	Labeling Change Control	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.	9449 units
Olympus Corporation of the Americas	510(k) number	2023-06-08	Class I	Under Investigation by firm	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.	1 units
Olympus Corporation of the Americas	510(k) number	2023-06-08	Class I	Under Investigation by firm	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.	9,684 units

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.