FDA.reportPublic FDA data

TAPES

Primary DI
05425029282094
Brand
TAPES
Company
Endo Tools Therapeutics
Model
TAPES
Device description
TAPES 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
05425029282391PackageGS112In Commercial Distribution
05425029282698PackageGS16In Commercial Distribution
05425029282919PackageGS196In Commercial Distribution
05425029282933PackageGS1192In Commercial Distribution
05425029282964PackageGS1240In Commercial Distribution
05425029282988PackageGS1144In Commercial Distribution
05425029282995PackageGS1288In Commercial Distribution
05425029282094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425029282391054250292823915425029282391
05425029282698054250292826985425029282698
05425029282919054250292829195425029282919
05425029282933054250292829335425029282933
05425029282964054250292829645425029282964
05425029282988054250292829885425029282988
05425029282995054250292829955425029282995
05425029282094054250292820945425029282094

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.

Storage And Handling#

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

Regulatory Flags#

DUNS number
400000750
Device count
1
Kit
true
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
05425029282018endomina platformendomina platform2022-07-19
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