Disposable Cytology Brush

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: DISPOSABLE CYTOLOGY BRUSH FDA UDI
Generic Name: Flexible endoscopic cytology brush, single-use FDA UDI
Model / Reference: BC-201C-1006 FDA UDI

Identifiers

Catalog Number: N6194340 FDA UDI
Primary DI / UDI-DI: 04953170453755 FDA UDI
510(k) Number: K013591 FDA UDI
FDA Product Code: EOB FDA UDI
GMDN Term: Flexible endoscopic cytology brush, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Flexible endoscopic cytology brush, single-use

Disposable Cytology Brush by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Flexible endoscopic cytology brush, single-use.

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CONMED — Conmed Corporation · Class II
CONMED — Conmed Corporation · Class I
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Infinity — US Endoscopy · Class II

Cleared under the same submission

K013591 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI ce002eed-45b9-4939-9d66-bc554d076b57 35 fields · synced May 31, 2026