X-Tack Endoscopic HeliX Tacking System

FDA UDI

Class II (US FDA UDI)

by Apollo Endosurgery

Identity

Trade Name: X-Tack Endoscopic HeliX Tacking System FDA UDI
Generic Name: Gastrointestinal endoscopic clip, short-term FDA UDI
Device Name: X-Tack Endoscopic HeliX Tacking System (160 cm) FDA UDI
Model / Reference: XTACK-160-H FDA UDI
Description: X-Tack Endoscopic HeliX Tacking System (160 cm) FDA UDI

Identifiers

Catalog Number: XTACK-160-H FDA UDI
Primary DI / UDI-DI: 10811955020763 FDA UDI
FDA Product Code: OCW FDA UDI
PKL FDA UDI
GMDN Term: Gastrointestinal endoscopic clip, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
876.4400 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Gastrointestinal endoscopic clip, short-term

X-Tack Endoscopic HeliX Tacking System by Apollo Endosurgery — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
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Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II

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: Apollo Endosurgery

Sources (1)

FDA UDI 18f164c2-0bfb-4e78-b3ae-886275be9ccd 35 fields · synced May 30, 2026