Disposable Endoscope Injection Needle

FDA UDI

Class II (US FDA UDI)

by Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Identity

Trade Name: Disposable Endoscope Injection Needle FDA UDI
Generic Name: Flexible endoscopic biopsy handpiece/needle FDA UDI
Model / Reference: FTL-IN-24-230-22-5 FDA UDI

Identifiers

Catalog Number: MMIN-22-5 FDA UDI
Primary DI / UDI-DI: 06936603226551 FDA UDI
510(k) Number: K220292 FDA UDI
FDA Product Code: FBK FDA UDI
GMDN Term: Flexible endoscopic biopsy handpiece/needle 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

Category: Flexible endoscopic biopsy handpiece/needle

Disposable Endoscope Injection Needle by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Flexible endoscopic biopsy handpiece/needle.

ClearTip — Finemedix Co., Ltd. · Class II
ClearTip — Finemedix Co., Ltd. · Class II
ClearTip — Finemedix Co., Ltd. · Class II
ViziShot FLEX — Gyrus Acmi, Inc. · Class II
ELMED — ELMED INCORPORATED · Class I
ClearTip — Finemedix Co., Ltd. · Class II
Aspirating Biopsy Needle — Auris Health, Inc. · Class II
Compass Steerable Needle — SERPEX MEDICAL, INC. · Class II

Cleared under the same submission

K220292 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: Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Sources (1)

FDA UDI 76009eca-14c7-4528-b628-431f078ac872 34 fields · synced May 30, 2026