What is FDA product code FDA?

To provide visualization and perform various procedures within the small intestine. 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 › DiagnosticEnteroscope And Accessories

Fujifilm

Name: Fujifilm
Brand: Fujifilm

This product is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the…

Registry build 21.09.26

This product is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians. Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

1manufacturer

6catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

Registered in Liaoning. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FDA
Manufacturer	City	Province	Registered as	Device types
Dalian Create Medical Products Co., Ltd.	Dalian	Liaoning	Contract manufacturer	2

Record

Regulatory record for Fujifilm
Listed by	Fujifilm Corporation, Japan
FDA product code	FDA
Device type	Enteroscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K040048
Record published	2016-12-14
Record revised	2024-06-10 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	High-level Disinfectant, Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Storage environment humidity 10 to 85 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Special storage condition: There must be no condensation.
Packaging	Box, box of 10

Catalogue Numbers

Catalogue numbers for Fujifilm
Catalogue number	Size	Status
EN-450P5/20		In distribution
TS-1214C		In distribution
EN-530T		In distribution
EN-840T		In distribution
EN-450T5		In distribution
BS-3		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	2
Balloon Control Unit	Olympus Medical Systems Corp.	2
Q Urological Persistent Aguamedicina	Q Urological Corporation	2
Evis Exera II Small Intestinal Videoscope	Olympus Medical Systems Corp.	2
Endoscope Position Detecting Unit	Olympus Medical Systems Corp.	2
CD138 + Cyclin D1	Biocare Medical, LLC	1
HealthMart	Strategic Sourcing Services LLC	1
TG-98 LM Synea 400	W&H Dentalwerk Bürmoos GmbH	1
Ancora	Aspero Medical, Inc.	1
Zeus-P	Spinal Elements, Inc.	1
Jade PTA Balloon Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	1
Premier Jackson Improved Short Tracheostomy Tube	Premier Dental Products Co.	1

Showing 12 of 19. All products under Enteroscope And Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213195	2021-10-29
K183032	2019-06-24
K183683	2019-02-27

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.