EndoTBrush Cytology Brush

FDA UDI

Class II (US FDA UDI)

by Endo-Therapeutics, Inc.

Identity

Trade Name: EndoTBrush Cytology Brush FDA UDI
Generic Name: Flexible endoscopic cytology brush, single-use FDA UDI
Device Name: Endoscopic cytology brush FDA UDI
Model / Reference: ET1427 FDA UDI
Description: Endoscopic cytology brush FDA UDI

Identifiers

Catalog Number: ET1427 FDA UDI
Primary DI / UDI-DI: 00816207021751 FDA UDI
510(k) Number: K800966 FDA UDI
FDA Product Code: FDX FDA UDI
GMDN Term: Flexible endoscopic cytology brush, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Yes

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

Dimensions & Sizes

Size: Length — 230 Centimeter FDA UDI
Outer Diameter — 2.4 Millimeter FDA UDI

Category: Flexible endoscopic cytology brush, single-use

EndoTBrush Cytology Brush by Endo-Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
CONMED — Conmed Corporation · Class II
Disposable Bronchial Cytology Brush — TeleMed Systems · Class II
CONMED — Conmed Corporation · Class II
CONMED — Conmed Corporation · Class I
DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II

Cleared under the same submission

K800966 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: Endo-Therapeutics, Inc.

Sources (1)

FDA UDI 4f28b0e8-f758-4e3d-80e6-def81ebde5c8 38 fields · synced Jun 1, 2026