Articulator

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name: Articulator FDA UDI
Generic Name: General-purpose endoscopic needle, single-use FDA UDI
Device Name: The Articulator enteroscope injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes. FDA UDI
Model / Reference: 00711808 FDA UDI
Description: The Articulator enteroscope injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes. FDA UDI

Identifiers

Catalog Number: 00711808 FDA UDI
Primary DI / UDI-DI: 00724995180867 FDA UDI
510(k) Number: K232826 FDA UDI
K971842 FDA UDI
FDA Product Code: FCG FDA UDI
FBK FDA UDI
GMDN Term: General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 FDA UDI
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

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 25 Gauge FDA UDI
Length — 350 Centimeter FDA UDI
Outer Diameter — 2.5 Millimeter FDA UDI

Category: General-purpose endoscopic needle, single-use

Articulator by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose endoscopic needle, single-use.

Single Use Aspiration Needle NA-U201H — Olympus Medical Systems Corporation · Class II
ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
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ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Injectra, ScleroTip — Medi-Globe Corporation · Class II
Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
Henry Schein — HENRY SCHEIN, INC. · Class I

Cleared under the same submission

K232826 also covers:

Articulator — US Endoscopy
Articulator — US Endoscopy

K971842 also covers:

Articulator — US Endoscopy
Articulator — US Endoscopy

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: US Endoscopy

Sources (1)

FDA UDI af8a9f31-016a-4fd3-95f4-80564d550221 38 fields · synced May 30, 2026