FDA.reportPublic FDA data

WECK

Primary DI
24026704558838
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN002709
Catalog number
EFX001
Device description
WECK ENDO FASCIAL CLOSURE SYSTEM
Published
2016-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K103412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103412000AXIOM FASCIAL CLOSURE SYSTEMAxiom Technology Partners, LLC2010-12-30OCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704558838PackageGS15In Commercial Distribution
44026704558832PackageGS12In Commercial Distribution
04026704558834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670455883824026704558838
4402670455883244026704558832
04026704558834040267045588344026704558834

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 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; it may in addition knot and/or cut the sutures as they are placed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10.25Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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