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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
Suture Cinch - Long FDA UDI
Model / Reference
CNH-C01-213-L FDA UDI
Description
Suture Cinch - Long FDA UDI

Identifiers

Catalog Number
CNH-C01-213-L FDA UDI
Primary DI / UDI-DI
10811955020756 FDA UDI
FDA Product Code
PKL FDA UDI
OCW FDA UDI
GMDN Term
Gastrointestinal endoscopic clip, short-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4400 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Gastrointestinal endoscopic clip, short-term.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apollo Endosurgery

Sources (1)

  • FDA UDI 864c5919-8903-460f-ba9b-92c33cd5b4ca 35 fields · synced May 30, 2026