FDA.reportPublic FDA data

EndoFix Tissue Fixation Device

Primary DI
00860014822704
Brand
EndoFix Tissue Fixation Device
Company
Endofix Medical Technologies, Inc.
Model
D6000000
Device description
EndoFix Tissue Fixation Device-Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based implant delivered through an 18 gaugeechogenic needle.
Published
2026-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts
OCWEndoscopic Tissue Approximation Device
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251229000EndoFix™Tissue Fixation SystemSoftac Medical Technologies2025-08-20FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014822704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014822704008600148227048600148227040860014822704

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145126274
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014822711Secure Suture Locking DeviceD50000002026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450456385ReSolve®Merit Medical Systems, Inc.FGE2026-11-04
00884450456286ReSolve®Merit Medical Systems, Inc.FGE2026-10-27
06936603238059HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238066HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238073HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
16926839818887NAAnrei Medical(HZ)Co., Ltd.PKL2026-10-19
16926839818917NAAnrei Medical(HZ)Co., Ltd.PKL2026-10-19
03760441721113Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441721212Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441722110Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441722219Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441723117Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
03760441723216Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18