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

Pathfinder® Endoscope Cap

Name: Pathfinder® Endoscope Cap
Brand: Pathfinder® Endoscope Cap

Catalogue number GI EC-0412-1, listed by Neptune Medical, Inc, United States, under Gastroscope And Accessories, Flexible/Rigid. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Pathfinder® Endoscope Cap
Listed by	Neptune Medical, Inc, United States
FDA product code	FDS
Device type	Gastroscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Complaint-file establishment, Manufacturer
Record published	2021-06-02
Record revised	2024-12-23 (version 3)

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
Sizes	Lumen/inner diameter 12 mm; depth 4 mm

Catalogue Numbers

Catalogue numbers for Pathfinder® Endoscope Cap
Catalogue number	Size	Status
GI EC-0412-1	Lumen/Inner Diameter 12 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K210915	2021-05-25

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.