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).

Ascope™ Colon · Colonoscope and Accessories, Flexible/Rigid → Gastroenterology & Urology

Name: aScope™ Colon
Brand: aScope™ Colon

9manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 aScope™ Colon
Listed by	Ambu A/S, Denmark
FDA product code	FDF
Device type	Colonoscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Private-label distributor, Manufacturer, Exporter
Record published	2023-11-02

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
Storage	Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 80 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment humidity 30 to 85 % RH; Storage environment temperature 10 to 25 °C
Packaging	Pack of 6

Catalogue Numbers

Catalogue numbers for aScope™ Colon
Catalogue number	Size	Status
484001000US		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
K230332	2023-09-15

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.

Ascope™ Colon