FasTouch™
The FasTouch Fixation System is intended to fix prosthetic material to soft tissue in minimally invasive and open surgical procedures, including hernia repairs. The FDA filing identifies…
The FasTouch Fixation System is intended to fix prosthetic material to soft tissue in minimally invasive and open surgical procedures, including hernia repairs. The FDA filing identifies the FasTouch Fixation System as the subject device.
The filing describes a manual laparoscopic instrument that facilitates hernia mesh delivery and placement. It is a single-use system designed to deliver a permanent fastener into tissue or prosthesis.
Listed Item
Sterile Sample of the FasTouch™ Permanent Reloadable Cartridge 10 Permanent Fasteners
System Configuration
The filing says the unloaded system contains a handle and cartridge and is designed for insertion through a laparoscopic port sleeve. Its stated indication covers fixation of prosthetic material to soft tissue.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Beijing Biosis Healing Biological Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Sinolinks Medical Innovation, Inc. | Changzhou | Jiangsu | Complaint-file establishment | 5 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
| Lucky Star Lrradiation Science Co., Ltd. Shanghai | Shanghai | Shanghai | Contract manufacturer | 5 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
| Medtronic (Shanghai) Medical Technology Co., Ltd. | Min Hang District | Shanghai | Specification developer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Staple, Implantable
Record
| Listed by | Via Surgical, Ltd., Israel |
|---|---|
| FDA product code | GDW |
| Device type | Staple, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4750 |
| 510(k) | K162252 |
| Record published | 2017-08-21 |
| Record revised | 2022-11-09 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5, box of 10 |
| Sizes | Outer diameter 5 mm; length 37 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FTP25 | Outer Diameter 5 mm | In distribution |
| SFTPC10 | Length 37 cm | In distribution |
| SFTP25 | Length 37 cm | In distribution |
| FTPC10 | Outer Diameter 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo GIA | Covidien LP | 51 |
| Aeon | Lexington Medical, Inc. | 48 |
| Proximate | Ethicon Endo-Surgery, Inc. | 42 |
| Tri-Staple 2.0 | Covidien LP | 42 |
| EEA | Covidien LP | 37 |
| Echelon Endopath | Ethicon Endo-Surgery, Inc. | 33 |
| Reloading Unit for Endo Linear Cutter Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 28 |
| GIA | Covidien LP | 24 |
| easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | Ezisurg Medical Co., Ltd. | 23 |
| Circular Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 23 |
| Endopath | Ethicon Endo-Surgery, Inc. | 22 |
| Signia | Covidien LP | 19 |
Showing 12 of 105. All products under Staple, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203117 | 2021-01-07 |
| K181668 | 2019-03-13 |
| K162252 | 2016-11-14 |
| K132698 | 2014-03-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.