What is FDA product code FDS?

To examine or perform procedures in the stomach. 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 · Gastroscope and Accessories, Flexible/Rigid → Gastroenterology & Urology

Name: Pentax
Brand: Pentax

9manufacturers in China registered for this device type

72catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Shanghai (2).

Chinese manufacturers registered for FDA product code FDS
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
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
Sumitomo Bakelite (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	3
Daichuan Medical (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	2

Record

Regulatory record for Pentax
Listed by	Hoya Corporation, Bulgaria
FDA product code	FDS
Device type	Gastroscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Manufacturer, Exporter
510(k)	K131902
Record published	2017-04-07
Record revised	2025-04-07 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization, Sound Waves, Ethylene Oxide, High-level Disinfectant
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number
Distribution end date	2024-10-10
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Pentax
Catalogue number	Per pack	Status
OF-B162		In distribution
AL-SL		In distribution
OF-B153		In distribution
OF-D3		In distribution
EG-2490K		In distribution
OF-B161		In distribution
OF-B127		In distribution
OF-B194		In distribution
OF-B170		In distribution
EG29-i10		In distribution
OE-C20		In distribution
OF-B118		In distribution
CS3030S		In distribution
OF-G17		In distribution
OF-B130		In distribution
OF-B194		In distribution
EG29-i10		In distribution
AL-OL10		In distribution
AL-OR3		In distribution
EG-3890TK		In distribution
OF-Z11		In distribution
EG-3890TK		In distribution
EG27-i10		In distribution
EG-290Kp		In distribution
EG-2990i		In distribution
OF-B195		In distribution
EG-2990i		In distribution
FG-29V		In distribution
OF-Z5		In distribution
KW2215S		Withdrawn
KW2211S		Withdrawn
AL-OLG11		Withdrawn
EG-2790K		Withdrawn
KW1815S		Withdrawn
AL-ML3		Withdrawn
KW2415S		Withdrawn
OF-B141		Withdrawn
EG-2990K		Withdrawn
AL-AL		Withdrawn
VSB-3430K		Withdrawn
OF-B123		Withdrawn
AL-OL7		Withdrawn
AL-MF3		Withdrawn
OF-B173	10	Withdrawn
OF-B135		Withdrawn
EE-1580K		Withdrawn
KW3115S		Withdrawn
EG-2990i		Withdrawn
FG-24V		Withdrawn
OF-B133		Withdrawn
EG-1690K		Withdrawn
OF-B35		Withdrawn
AL-WL		Withdrawn
AL-OL9		Withdrawn
OF-B111		Withdrawn
EG29-i10		Withdrawn
EG29-i10		Withdrawn
KW2218CS		Withdrawn
AL-OL11		Withdrawn
EG-2990i		Withdrawn
KW3122S		Withdrawn
KW2430S		Withdrawn
KW1511S		Withdrawn
EG-3490K		Withdrawn
OF-B132		Withdrawn
EG-2490K		Withdrawn
EG-2790i		Withdrawn
KW1818S		Withdrawn
KW3111S		Withdrawn
EG27-i10		Withdrawn
EG-1690K		Withdrawn
OE-A41	20	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fujifilm	Fujifilm Corporation	43
Disposable Distal Attachment	Olympus Medical Systems Corp.	27
Disposable Distal Cap	Micro-Tech (Nanjing) Co., Ltd.	26
Video Gastroscope	Pentax of America, Inc.	20
Gyrus Acmi	Gyrus Acmi, Inc.	18
Medisono	Medisono, LLC	18
Gastroscope And Accessories, Flexible/Rigid	Karl Storz GmbH & Co. KG	17
Distal Attachment	Olympus Medical Systems Corp.	14
Disposable EMR KIT	Olympus Medical Systems Corp.	12
Fuse®	Endochoice, Inc.	11
Evis Exera II Gastrointestinal Videoscope	Olympus Medical Systems Corp.	9
Pentax Medical	Hoya Corporation	9

Showing 12 of 66. All products under Gastroscope And Accessories, Flexible/Rigid

Recalls Naming This Product

3 recalls name this product by its own identifiers, 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	2016-08-15	Class II	Labeling Change Control	PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.	3,436 (US) and 14,488 (OUS)	2019-04-23
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.	9,669 units	2017-12-21
Pentax of America, Inc.	510(k) number	2014-06-12	Class II	Device Design	Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the us	531 units	2015-11-17

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.

Pentax