TissueTak™
TissueTak is a sterile, single-use system designed to deliver an absorbable fastener into tissue and prosthetic material. The fastener ends lock together to form a closed loop that affixes…
TissueTak is a sterile, single-use system designed to deliver an absorbable fastener into tissue and prosthetic material. The fastener ends lock together to form a closed loop that affixes mesh or a patch to soft tissue.
The FDA indication covers fixation of prosthetic or biologic material during minimally invasive and open procedures, including hernia or rotator cuff repairs. The system is designed for insertion through a laparoscopic port sleeve at least five millimeters in size.
Listed Item
TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners Tendon Anchor Device in Rotator Cuff Augmentation Kit
Fastener Design
The fasteners are made from PURASORB PLG 8218 with D&C violet No. 2 dye. The summary states the TissueTak submission clarified the intended-use wording to include rotator cuff repair.
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) | K203117 |
| Record published | 2021-03-04 |
| Record revised | 2022-11-09 (version 2) |
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 |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Box of 5, box of 10 |
| Sizes | Outer diameter 5 mm; length 20.9 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS-19022TT | Outer Diameter 5 mm | In distribution |
| AR-19021TT-1 | Outer Diameter 5 mm | In distribution |
| AR-19021TT | Outer Diameter 5 mm | In distribution |
| AS-19021TT | 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.