FDA.reportPublic FDA data

endomina EZFuse suture

Primary DI
05425029282643
Brand
endomina EZFuse suture
Company
Endo Tools Therapeutics
Model
endomina EZFuse suture
Device description
endomina EZFuse suture
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCWEndoscopic Tissue Approximation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252400000Endomina EZFuse systemEndo Tools Therapeutics S.A.2026-02-13OCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425029282131PackageGS18In Commercial Distribution
05425029282346PackageGS112In Commercial Distribution
05425029282384PackageGS120In Commercial Distribution
05425029282452PackageGS112In Commercial Distribution
05425029282643PackageGS16In Commercial Distribution
05425029282766PackageGS116In Commercial Distribution
05425029282889PackageGS124In Commercial Distribution
05425029282049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425029282131054250292821315425029282131
05425029282346054250292823465425029282346
05425029282384054250292823845425029282384
05425029282452054250292824525425029282452
05425029282643054250292826435425029282643
05425029282766054250292827665425029282766
05425029282889054250292828895425029282889
05425029282049054250292820495425029282049

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400000750
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05425029282049endomina EZFuse sutureendomina EZFuse suture2026-03-19
05425029282087endomina EZFuse systemendomina EZFuse system2026-03-19
05425029282599endomina EZFuse systemendomina EZFuse system2026-03-19
05425029282018endomina platformendomina platform2022-07-19
05425029282094TAPESTAPES2022-07-19
05425029282070endomina systemendomina system2022-07-19
05425029282117endomina platformendomina platform2022-07-19
05425029282698TAPESTAPES2022-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083048020SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048037SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048044SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048051SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048082SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048112SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048136SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
14026704937056MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937063MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937070MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937087MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937094MINILAPTELEFLEX INCORPORATEDOCW2026-03-30
05425029282049endomina EZFuse sutureEndo Tools TherapeuticsOCW2026-03-19
05425029282087endomina EZFuse systemEndo Tools TherapeuticsOCW2026-03-19
05425029282599endomina EZFuse systemEndo Tools TherapeuticsOCW2026-03-19
00860014822704EndoFix Tissue Fixation DeviceEndofix Medical Technologies, Inc.OCW2026-02-02
00860014822711Secure Suture Locking DeviceEndofix Medical Technologies, Inc.OCW2026-02-02
00191506060091OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-09-19
00191506060053Tissue HelixBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506049126OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506060138OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506049188NABOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506060046OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
14026704737946MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737953MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737960MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737977MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
24026704737943MINILAPTELEFLEX INCORPORATEDOCW2024-11-05