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

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.

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
06959664915868NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915875NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915882NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915899NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915912NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915936NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915943NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915950NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915967NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915974NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915981NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916094NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916100NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916117NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916124NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916131NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916292NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916308NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916315NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916322NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916339NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916346NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916353NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916360NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916490NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916506NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916513NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916520NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916537NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916698NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23