SubQ It!
SubQ It! is a bioabsorbable skin-closure system for temporary approximation of tissue beneath the skin surface. Its applications include abdominal, thoracic, gynecological, orthopedic,…
SubQ It! is a bioabsorbable skin-closure system for temporary approximation of tissue beneath the skin surface. Its applications include abdominal, thoracic, gynecological, orthopedic, plastic and reconstructive surgery when an absorbable tissue fastener is desired.
A manual stapler inserts preloaded fasteners into the tissue. Each fastener has two legs with barbed tips, spaced 2.75 mm apart from centre to centre. The legs are 4.3 mm long and 0.88 mm in diameter.
Listed Item
SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
Fastener Material and Supply
The fasteners are made from an 82/18 L-lactide/glycolide copolymer that is bioabsorbable. They are preloaded into the stapler, sterilized by gamma radiation and packaged for use with a single patient.
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 | Opus KSD, Inc., United States |
|---|---|
| FDA product code | GDW |
| Device type | Staple, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4750 |
| Establishment | Manufacturer |
| 510(k) | K131563 |
| Record published | 2016-08-30 |
| Record revised | 2019-08-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Shelf box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 404010 | In distribution | |
| SF10 | 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 |
|---|---|
| K131563 | 2014-04-09 |
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.