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).

Gastroenterology & Urology › DiagnosticGastroscope And Accessories, Flexible/Rigid

Saneso

Name: Saneso
Brand: Saneso

Saneso Gastroscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging,…

Registry build 21.09.26

Saneso Gastroscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging, vertical & horizontal bending radius of 180 degrees & 160 degrees, preserved mechanical characteristics, and a continuous guide view™ of the lumen.

9manufacturers in China registered for this device type

2catalogue 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 Saneso
Listed by	Saneso, Inc., United States
FDA product code	FDS
Device type	Gastroscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
510(k)	K210052
Record published	2022-11-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Sizes	Length 1040 mm; outer diameter 11.6 to 15.6 mm

Catalogue Numbers

Catalogue numbers for Saneso
Catalogue number	Size	Status
SAN360G-A	Length 1040 mm	In distribution
SAN1G-A	Length 1040 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pentax	Hoya Corporation	72
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

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

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.