FDA.reportPublic FDA data

endomina platform

Primary DI
05425029282018
Brand
endomina platform
Company
Endo Tools Therapeutics
Model
endomina platform
Device description
endomina platform primary packaging (x1)
Published
2022-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
K211309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211309000endomina systemEndo Tools Therapeutics S.A.2021-12-07OCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425029282117PackageGS11In Commercial Distribution
05425029282339PackageGS14In Commercial Distribution
05425029282926PackageGS116In Commercial Distribution
05425029282940PackageGS14In Commercial Distribution
05425029282957PackageGS112In Commercial Distribution
05425029282018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425029282117054250292821175425029282117
05425029282339054250292823395425029282339
05425029282926054250292829265425029282926
05425029282940054250292829405425029282940
05425029282957054250292829575425029282957
05425029282018054250292820185425029282018

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic overtube, single-use"A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be ""shape locked"" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device."

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
400000750
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
05425029282643endomina EZFuse sutureendomina EZFuse suture2026-03-19
05425029282599endomina EZFuse systemendomina EZFuse system2026-03-19
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
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
05425029282643endomina EZFuse sutureEndo 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
34026704737957MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
34026704737964MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
24026704737974MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
00811955020834OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.OCW2024-10-01
10884521826267MaxTackCovidien LPOCW2024-09-09
20884521826264MaxTackCovidien LPOCW2024-09-09