Data / Medical devices / Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile (NNY): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile (product code NNY, Class 1, 21 CFR 876.5250). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NNY
- Device class
- 1
- Regulation
- 876.5250
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| United States | 2 |
| Mexico | 2 |
Makers of Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
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 |
|---|---|---|---|---|---|---|---|---|
| Acanthus Medical Creations, LLC | Wauconda, IL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fesun Shanghai Co., Ltd. | shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JM Medical Co., Ltd. | Liaocheng Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Sitaili Medical Apparatus Development Co.,ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.