FDA.reportPublic FDA data

FasTouch™

Primary DI
07290017155111
Brand
FasTouch™
Company
VIA SURGICAL LTD
Model
FTPC10
Catalog number
FTPC10
Device description
FasTouch™ Permanent Reloadable Cartridge10 Permanent Fasteners
Published
2017-08-21
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
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162252000FasTouch Fixation SystemVia Surgical , Ltd.2016-11-14GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017155118PackageGS110In Commercial Distribution
07290017155111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001715511817290017155118
07290017155111072900171551117290017155111

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic manual linear staplerA sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length37Centimeter
Outer Diameter5Millimeter

Contacts#

Phone, Email table
PhoneEmail
+18009696331CS@progressivemedinc.com

Regulatory Flags#

DUNS number
600319250
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017155012FasTouch™SFTP25SFTP252017-08-29
07290017155210FasTouch™ AbsorbableFTA25FTA252019-09-14
07290017155241FasTouch™ AbsorbableSFTA25SFTA252019-09-14
07290017155272FasTouch™ AbsorbableFTAC10FTAC102019-09-14
07290017155289FasTouch™ AbsorbableSFTAC10SFTAC102019-09-14
07290017155302TissueTak™AR-19021TTAR-19021TT2021-02-04
07290017155340TissueTak™AS-19021TTAS-19021TT2021-02-04
07290017155364TissueTak™AR-19021TT-1AR-19021TT-12021-12-01
07290017155357TissueTak™AS-19022TTAS-19022TT2021-03-04
07290017155104FasTouch™FTP25FTP252017-08-21
17290017155309TissueTak™AR-19021TTAR-19021TT2021-02-04
17290017155347TissueTak™AS-19021TTAS-19021TT2021-02-04
17290017155019FasTouch™SFTP25SFTP252017-08-29
17290017155217FasTouch™ AbsorbableFTA25FTA252019-09-14
17290017155248FasTouch™ AbsorbableSFTA25SFTA252019-09-14
17290017155279FasTouch™ AbsorbableFTAC10FTAC102019-09-14
17290017155286FasTouch™ AbsorbableSFTAC10SFTAC102019-09-14
07290017155043FasTouch™SFTPC10SFTPC102017-08-29
17290017155040FasTouch™SFTPC10SFTPC102017-08-29
17290017155118FasTouch™FTPC10FTPC102017-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
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
16953886000477TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000484TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000491TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000514TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000521TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000569TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27