FDA.reportPublic FDA data

g-Cath Suture Anchor Delivery Catheter

Primary DI
00860009064713
Brand
g-Cath Suture Anchor Delivery Catheter
Company
Usgi Medical, Inc.
Model
g-Cath EZ
Catalog number
208100
Device description
g-Cath Suture Anchor Delivery Catheter
Published
2022-12-20
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GDWStaple, Implantable
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
GDWStaple, ImplantableGeneral, Plastic Surgery2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102916000G-CATH TISSUE ANCHOR DELIVERY CATHETERUsgi Medical2010-10-20GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009064710PackageGS16In Commercial Distribution
00860009064713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000906471010860009064710
00860009064713008600090647138600090647130860009064713

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Regulatory Flags#

DUNS number
112331090
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009064706Transport Endoscopic Access DeviceTransport Retroflex1181802022-12-20
00860009064720g-Prox EZ Endoscopic Grasperg-Prox EZ-162082002022-12-20
00860009064737g-Prox EZ Endoscopic Grasperg-Prox EZ-332082202022-12-20
00860009064744g-Lix Tissue Grabberg-Lix3010102022-12-20
00860009064751Transport Endoscopic Access DeviceTransport-R5001002022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007711251EasyWhipWinter Innovations Inc.GAT2026-08-01
00860007711275EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630712EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630743EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630750EasyWhipWinter Innovations Inc.GAT2026-08-01
00860014630767EasyWhipWinter Innovations Inc.GAT2026-08-01
14026704724441DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704724861DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
14026704725042DEKNATELTELEFLEX INCORPORATEDGAT2026-08-01
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
14026704723857DEKNATELTELEFLEX INCORPORATEDGAT2026-07-29
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000439TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000446TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000453TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000460TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27