Ethicon Securestrap
Ethicon SecureStrap mechanically fixes prosthetic material such as surgical mesh to soft tissue. A trigger-operated applicator places absorbable straps into the tissue of the abdominal…
Ethicon SecureStrap mechanically fixes prosthetic material such as surgical mesh to soft tissue. A trigger-operated applicator places absorbable straps into the tissue of the abdominal wall.
The Open configuration uses a curved cannula preloaded with 20 straps and is designed for open surgical repair. It is one delivery configuration within a family that also includes a 5 mm fixation device.
Listed Item
Ethicon Securestrap Absorbable Fixation Device
Strap and Applicator Design
The straps blend polydioxanone with an L-lactide/glycolide copolymer and contain violet dye. In the Open device, the inserted strap length is 6.7 mm. Its handle, trigger, lockout counter and mesh-positioning tip form the delivery mechanism around the absorbable fixation elements.
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 | Ethicon, Inc., United States |
|---|---|
| FDA product code | GDW |
| Device type | Staple, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4750 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K123114 |
| Record published | 2024-03-13 |
| Record revised | 2026-05-19 (version 10) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 30 °C |
| Packaging | Box of 6 |
| Distribution end date | 2019-05-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPSTRAP20R | In distribution | |
| OPSTRAP20 | In distribution | |
| STRAP12 | In distribution | |
| STRAP25 | In distribution | |
| STRAP12R | In distribution | |
| STRAP25R | In distribution | |
| OPENSTRAP20 | Withdrawn |
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 |
|---|---|
| K123114 | 2013-02-05 |
| K093845 | 2010-04-07 |
| K920752 | 1992-08-06 |
| K915693 | 1992-03-19 |
| K913139 | 1991-09-06 |
| K890841 | 1989-04-19 |
| K843034 | 1984-09-17 |
| K822345 | 1982-09-21 |
| K821994 | 1982-08-03 |
| K801154 | 1980-06-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | 510(k) number | 2010-12-29 | Not classified | Pending | The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging. | 4,110 | 2012-11-07 |
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.