FDA.reportPublic FDA data

X-Tack Endoscopic HeliX Tacking System

Primary DI
10811955020756
Brand
X-Tack Endoscopic HeliX Tacking System
Company
Apollo Endosurgery, Inc.
Model
CNH-C01-213-L
Catalog number
CNH-C01-213-L
Device description
Suture Cinch - Long
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
20811955020753PackageGS16In Commercial Distribution
10811955020756PrimaryGS10
00811955020759Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081195502075320811955020753
1081195502075610811955020756
00811955020759008119550207598119550207590811955020759

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
6
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
10811955020770X-Tack Endoscopic HeliX Tacking SystemXTACK-235-HXTACK-235-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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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