What is FDA product code FDX?

To collect cells for cytological evaluation.

Gastroenterology & Urology › DiagnosticEndoscopic Cytology Brush

Single Use Cytology Brush V

Name: Single Use Cytology Brush V
Brand: Single Use Cytology Brush V

2 catalogue numbers from BC-V600P-3010, listed by Olympus Medical Systems Corp., Japan, under Endoscopic Cytology Brush. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (2), Shanghai (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code FDX
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Chuangxiang Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Jiana Sterilization Technology (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	23
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13

Record

Regulatory record for Single Use Cytology Brush V
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	FDX
Device type	Endoscopic Cytology Brush
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K902737
Record published	2016-09-21
Record revised	2024-04-22 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Single Use Cytology Brush V
Catalogue number	Size	Status
BC-V600P-3010		In distribution
BC-V600P-3010		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Single Use Cytology Brush	Zhejiang Chuangxiang Medical Technology Co., Ltd.	21
Conmed	ConMed Corporation	12
Halyard	Avanos Medical, Inc.	8
Cytology Brush	Avanos Medical, Inc.	8
Cook	Cook Incorporated	7
Cytology Brush	Micro-Tech (Nanjing) Co., Ltd.	7
Hobbs Medical Cytology Brush	Hobbs Medical, Inc.	6
Infinity	Us Endoscopy	6
Disposable Gastrointestinal Cytology Brush	TeleMed Systems	6
EndoTBrush Cytology Brush	Endo-Therapeutics, Inc.	5
CytoMax II	Cook Incorporated	5
Foreign Body Retrieval Basket	Avanos Medical, Inc.	5

Showing 12 of 27. All products under Endoscopic Cytology Brush

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250993	2025-12-18

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.