FDA.reportPublic FDA data

neoClose AnchorGuide 8/15 Port Closure Kit US (1 Port)

Primary DI
05391529640194
Brand
neoClose AnchorGuide 8/15 Port Closure Kit US (1 Port)
Company
NEOSURGICAL LIMITED
Model
NCAG815-U
Device description
Laparoscopy wound closure system kit consists of: 05391529640187; neoClose AnchorGuide 8/15 US; Model Number NCA815-U; Qty 10 and 05391529640156; neoClose 2 AutoAnchor Pack US; Model Number NCAA2-U; Qty 10
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142903000neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack USNeosurgical, Ltd.2014-11-12GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391529640200PackageGS14In Commercial Distribution
05391529640194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529640200053915296402005391529640200
05391529640194053915296401945391529640194

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic wound closure threadA sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.

Regulatory Flags#

DUNS number
896844250
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391529640460neoClose AnchorGuardNCAG-U2018-07-03
05391529640552neoClose 2 Anchor (Long Driver) USNCAALX2-U2018-07-03
05391529640477neoClose AnchorGuardNCAG-U2018-07-03
05391529640569neoClose 2 Anchor (Long Driver) USNCAALX2-U2018-07-03
05391529640064neoClose AnchorGuide XL Port Closure Kit US NCAGXL-U2016-11-11
05391529640088neoClose AnchorGuide Regular Port Closure Kit x2 US NCAGRX2-U2016-11-11
05391529640101neoClose 2 AutoAnchor Pack US NCAAX2-U2016-11-11
05391529640125neoClose 4 AutoAnchor Pack US NCAAX4-U2016-11-11
05391529640163neoClose AnchorGuide 5/12 Port Closure Kit US (1 Port)NCAG512-U2016-11-11
05391529640224neoClose AnchorGuide 5/15 Port Closure Kit US (2 Port)NCAG515(2)-U2016-11-11
05391529640026neoClose AnchorGuide Regular Port Closure Kit US NCAGR-U2016-11-11
05391529640071neoClose AnchorGuide XL Port Closure Kit US NCAGXL-U2016-11-11
05391529640095neoClose AnchorGuide Regular Port Closure Kit x2 UNCAGRX2-U2016-11-11
05391529640118neoClose 2 AutoAnchor Pack US NCAAX2-U2016-11-11
05391529640132neoClose 4 AutoAnchor Pack US NCAAX4-U2016-11-11
05391529640170neoClose AnchorGuide 5/12 Port Closure Kit US (1 PNCAG512-U2016-11-11
05391529640200neoClose AnchorGuide 8/15 Port Closure Kit US (1 PNCAG815-U2016-11-11
05391529640231neoClose AnchorGuide 5/15 Port Closure Kit US (2 PNCAG515(2)-U2016-11-11

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B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
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00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
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