FDA.reportPublic FDA data

6.5mm Cartridge

Primary DI
00810275013014
Brand
6.5mm Cartridge
Company
ENDOGASTRIC SOLUTIONS, INC.
Model
R2165
Device description
"Cartridge, 20 Fasteners, 0.010"" Slot, 6.5mm Web"
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142113000ESOPHYX2 HDEndogastric Solutions, Inc.2014-09-30ODE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810275013014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810275013014008102750130148102750130140810275013014

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suturing unit, single-useA sterile, manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
425-307-9269customerservice@endogastricsolutions.com

Regulatory Flags#

DUNS number
143602659
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810275014011SerosaFuse® Implantable Fastener KitR2275R22752019-03-14
00810275013052SerosaFuse® 7.5mm Implantable Fastener CartridgesR2375R23752019-03-13
00810275011065EsophyX2 HDR20052015-10-24
00810275011072EsophyX ZR20062015-10-24
008102750130217.5mm CartridgeR21752015-10-24
008102750130386.5mm & 7.5mm CartridgeR21672015-10-24
00810275011089EsophyX Z+R2007R20072017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450848135SerosaFuse®Merit Medical Systems, Inc.ODE2026-02-03
00884450848111EsophyX® Z+Merit Medical Systems, Inc.ODE2026-01-14
00884450848128SerosaFuse®Merit Medical Systems, Inc.ODE2026-01-14
00810275014011SerosaFuse® Implantable Fastener KitENDOGASTRIC SOLUTIONS, INC.ODE2019-03-14
00810275013052SerosaFuse® 7.5mm Implantable Fastener CartridgesENDOGASTRIC SOLUTIONS, INC.ODE2019-03-13
00810275011089EsophyX Z+ENDOGASTRIC SOLUTIONS, INC.ODE2017-11-16
07290014036062MUSE EndostaplerMEDIGUS LTDODE2016-09-20
07290014036529MUSE ConsoleMEDIGUS LTDODE2016-09-20
00810275011065EsophyX2 HDENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
00810275011072EsophyX ZENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130217.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130386.5mm & 7.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
07290014036079MUSE Staple CartridgeMEDIGUS LTDODE2015-09-24