Data / Medical devices / Ring (Wound Protector), Drape Retention, Internal
Ring (Wound Protector), Drape Retention, Internal (KGW): 20 FDA-registered makers in 7 countries
20 establishments in 7 countries are registered with the FDA to make Ring (Wound Protector), Drape Retention, Internal (product code KGW, Class 2, 21 CFR 878.4370). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on April 24, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KGW
- Device class
- 2
- Regulation
- 878.4370
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 3 |
| China | 3 |
| Taiwan | 2 |
| Netherlands | 1 |
| Germany | 1 |
| Japan | 1 |
Makers of Ring (Wound Protector), Drape Retention, Internal
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 |
|---|---|---|---|---|---|---|---|---|
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 3 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 3 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Europe | Amersfoort Utrecht, Netherlands | Exporter to the US, Manufacturer | 1 | January 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| 3M Edumex, S.A De C.V | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geister Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hakko Co., Ltd. | CHIKUMA-SHI Nagano, Japan | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Whippany, NJ, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Haize Medical Scientific Development Co.,Ltd. | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SOLVENTUM US LLC (Apodaca) | Apodaca Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgentec LLC | Boca Raton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | New Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimax Medical Systems Inc. | Yilan County, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VLV Associates, Inc. | Whippany, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 24, 2026. 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.