Data / Medical devices / Endoscope Introducer Kit
Endoscope Introducer Kit (NWU): 19 FDA-registered makers in 5 countries
19 establishments in 5 countries are registered with the FDA to make Endoscope Introducer Kit (product code NWU, Class 2, 21 CFR 876.1500). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on February 10, 1994, and lists 23 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- NWU
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 5 |
| China | 3 |
| Honduras | 1 |
| Turkey | 1 |
Makers of Endoscope Introducer Kit
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 |
|---|---|---|---|---|---|---|---|---|
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - SPT | Waukegan, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc | Chester, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medivators Inc | Conroe, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Soluciones Medicas | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S. | Tekirdag, Turkey | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 10, 1994. 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.