FDA.reportPublic FDA data

X-Tack Endoscopic HeliX Tacking System

Primary DI
10811955020770
Brand
X-Tack Endoscopic HeliX Tacking System
Company
Apollo Endosurgery, Inc.
Model
XTACK-235-H
Catalog number
XTACK-235-H
Device description
X-Tack Endoscopic HeliX Tacking System (235 cm)
Published
2021-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCWEndoscopic Tissue Approximation Device
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811955020777PackageGS13In Commercial Distribution
10811955020770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081195502077720811955020777
1081195502077010811955020770

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
855-551-3123productcomplaints.us@apolloendo.com

Regulatory Flags#

DUNS number
625064352
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811955020834OverStitch NXT Endoscopic Suturing SystemESS-ESG-NXTESS-ESG-NXT2024-10-01
10811955020619ORBERA Intragastric Balloon SystemB-4800B-48002015-08-24
00811955020919NXT Tissue Helix ProNXT-THXP-130 NXT-THXP-1302023-11-16
00811955020896OverStitch NXT Endoscopic Suturing SystemESS-G02-NXTESS-G02-NXT2023-11-16
10811955020916NXT Tissue Helix ProNXT-THXP-130 NXT-THXP-1302023-11-16
00811955020933Apollo ESG NXT SystemAPL-ESG-NXTAPL-ESG-NXT2023-11-16
00811955020940Apollo Revise NXT SystemAPL-REV-NXTAPL-REV-NXT2023-11-16
10811955020763X-Tack Endoscopic HeliX Tacking SystemXTACK-160-HXTACK-160-H2021-07-12
00811955020735OverStitch Endoscopic Suturing SystemPLY-G02-020-APLPLY-G02-020-APL2019-10-31
10811955020718OverStitch Endoscopic Suturing System SxESS-G02-Sx1ESS-G02-Sx12021-05-26
10811955020664OverStitch Endoscopic Suturing SystemESS-G02-160ESS-G02-1602016-08-19
10811955020671OverStitch Endoscopic Suturing SystemCNH-G01-000CNH-G01-0002016-08-19
10811955020688OverStitch Endoscopic Suturing SystemTHX-165-028THX-165-0282016-10-07
10811955020756X-Tack Endoscopic HeliX Tacking SystemCNH-C01-213-LCNH-C01-213-L2021-07-12
00811955020827Apollo 2-0 Polypropylene Endobariatric SuturePLY-G02-020-BAR2023-01-10
00811955020780APOLLO ESG™ SystemAPL-ESG-1602023-01-10
00811955020797APOLLO ESG Sx™ SystemAPL-ESG-SX12023-01-10
00811955020803APOLLO Revise™ SystemAPL-REV-1602023-01-10
00811955020810APOLLO REVISE™ Sx SystemAPL-REV-Sx12023-01-10
10811955020824Apollo 2-0 Polypropylene Endobariatric SuturePLY-G02-020-BAR2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913482NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915387NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915394NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915400NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915417NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915424NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915431NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915448NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915455NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915462NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915479NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915493NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915509NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915516NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915523NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915530NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915547NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915554NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915561NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915578NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915592NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915615NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915622NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915639NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915646NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915653NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915660NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915677NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915684NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915691NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16