Data / Medical devices / System, Skin Closure
System, Skin Closure (MKY): 22 FDA-registered makers in 6 countries
22 establishments in 6 countries are registered with the FDA to make System, Skin Closure (product code MKY, Class 1, 21 CFR 878.4320). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 15, 2001, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MKY
- Device class
- 1
- Regulation
- 878.4320
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| United States | 7 |
| South Korea | 2 |
| Canada | 2 |
| Mexico | 1 |
| Israel | 1 |
Makers of System, Skin Closure
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfix | GIMPO Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei V-Medical Products Co., Ltd. | Xiantao Hubei, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventorr MD Inc | Toronto Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivt Medical Ltd. | Raanana Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hysent Medical Technology Co., Ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chinmed Technology Co.,Ltd | ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepin MFG., Inc. | Lake City, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonele Inc. | Markham Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stabiliz Orthopaedics | Exton, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surginus Co.,ltd. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suturegard Medical, Inc. | Corvallis, OR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinhua Surgical Instrument Co. Ltd. | ZIBO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTD | Wenzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 15, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.