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
Code	Name
FGE	Stents, Drains And Dilators For The Biliary Ducts
OCW	Endoscopic Tissue Approximation Device
PKL	Hemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	2
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K251229	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K251229	000	EndoFix™Tissue Fixation System	Softac Medical Technologies	2025-08-20	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860014822704	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860014822704	00860014822704	860014822704	0860014822704

GMDN Terms#

Term, Definition table
Term	Definition
Gastrointestinal endoscopic clip, short-term	A 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 DI	Brand	Model	Catalog	Published
00860014822711	Secure Suture Locking Device	D5000000		2026-02-02

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
08714729504764	Resolution Clip	BOSTON SCIENTIFIC CORPORATION	PKL	2016-09-24
08714729504795	Resolution Clip	BOSTON SCIENTIFIC CORPORATION	PKL	2016-09-24
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

EndoFix Tissue Fixation Device

Related Records#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Sterilization Methods#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#